The document summarizes 90 critical care clinical trials covering important topics in intensive care. It focuses on the randomization method, excluded populations, and conclusions of each trial. The summaries are brief and not meant to replace reading the full text, but to provide a quick overview of the currently available evidence in critical care medicine.

1. Landmark Critical Care Clinical
Trials
By
Dr. Sherif Badrawy
Landmarks Critical Care
Dr. Sherif Badrawy

2.  Dear colleagues this is a collection of about 90 Critical Care clinical
trials which I think cover many important topics daily faced by us in the
ICU.
 This summary isn’t for research purposes as it doesn’t contain the full
details of every trial but for quick revision of the currently available
literature in the field of Critical Care Medicine.
 I focused mostly on the randomization method of the trial & the
excluded population out of the trial plus the conclusion of the trial.
 Again this’s not a replacement of the full text but a trial to sum up some
important data.
 Your valuable comments are highly appreciated.
Landmarks Critical Care
Dr. Sherif Badrawy

3. COMMIT ➜ Chen2005 ➜ Early use
of metoprolol in acute MI
〚Randomization〛
1a
Landmarks Critical Care
Dr. Sherif Badrawy
Dr. Sherif
Badrawy
Digitally signed by Dr. Sherif
Badrawy
DN: cn=Dr. Sherif Badrawy, o,
ou=Critical Care Medicine,
email=sherif_badrawy@yaho
o.com, c=SA
Date: 2015.05.05 01:56:28
+03'00'

4. ❐ Randomized to placebo vs. metoprolol IV
5 mg x 3 doses Q 3min (unless HR <50 or SBP < 90),
then metoprolol 50 mg PO Q 6hr (days 0-1 ), then
metoprolol succinate XL 200 mg daily (days 2-28)
❐ Excluded those with systolic BP < 100 mmHg,
heart rate < 50 bpm, heart block, cardiogenic shock,
or primary PCI (study was 2x2 factorial with
clopidogrel)
1b
Landmarks Critical Care
Dr. Sherif Badrawy

5. COMMIT ➜ Chen2005 ➜ Early use
of metoprolol in acute MI
〚Conclusion〛
2a
Landmarks Critical Care
Dr. Sherif Badrawy

6. ❀ The use of early, aggressive-dose metoprolol in
acute MI decreased arrhythmias and reinfarction,
but increased cardiogenic shock especially during
the first day or so after admission.
❀ Consequently, it might generally be prudent to
consider starting beta-blocker therapy in hospital
only when the haemodynamic condition after Ml
has stabilised
2b
Landmarks Critical Care
Dr. Sherif Badrawy

7. DOSE ➜ Felker 2011 ➜ Furosemide
bolus vs. infusion, low vs. high dose
in decompensated heart failure
〚Randomization〛
3a
Landmarks Critical Care
Dr. Sherif Badrawy

8. ❐ Randomized in 2x2 factorial design to low-dose
furosemide (daily IV dose equal to daily home PO dose) or
high-dose furosemide (daily IV dose equal to 2.5 times daily
home PO dose), and randomized to either bolus (dosed Q1
2h) or continuous infusion for 72 hours. A 50% dose increase
ws optional at 48 hours.
❐ Excluded patients with systolic BP < 90 mmHg,
creatinine> 3 mg/dL, and thosereceiving IV vasodilators or
inotropic agents (other than digoxin)
3b
Landmarks Critical Care
Dr. Sherif Badrawy

9. DOSE ➜ Felker 2011 ➜ Furosemide
bolus vs. infusion, low vs. high dose
in decompensated heart failure
〚Conclusion〛
4a
Landmarks Critical Care
Dr. Sherif Badrawy

10. ❀ There is no clinical advantage to a high
dose vs. low-dose furosemide strategy or
bolus vs. continuous infusion furosemide.
❀ There may be a small signal of
subjective benefit in high-dose patients,
but high dose was more associated with a
small increase in serum creatinine.
4b
Landmarks Critical Care
Dr. Sherif Badrawy

11. ESCAPE ➜ Binanay 2005 ➜
Efficacy of PA catheters in
decompensated heart failure
〚Randomization〛
5a
Landmarks Critical Care
Dr. Sherif Badrawy

12. ❐ Randomized patients to receive
clinical assessment only vs. clinical
assessment with a pulmonary
arterial catheter (PAC)
5b
Landmarks Critical Care
Dr. Sherif Badrawy

13. ESCAPE ➜ Binanay 2005 ➜
Efficacy of PA catheters in
decompensated heart failure
〚Conclusion〛
6a
Landmarks Critical Care
Dr. Sherif Badrawy

14. ❀ The use of a PA catheter (PAC) as an
adjunct to clinical judgment alone showed
no mortality or hospitalization benefit.
❀ Patients randomized to PACs had a
transient improvement in symptoms, but
experienced a higher rate of complications
as a result of PAC placement.
6b
Landmarks Critical Care
Dr. Sherif Badrawy

15. IAP-SHOCK II ➜ Thiele 2012 ➜
lntraaortic balloon support in ACS
with early revascularization
〚Randomization〛
7a
Landmarks Critical Care
Dr. Sherif Badrawy

16. ❐ Randomized to intraaortic balloon
pump (IABP) or no IABP (control)
7b
Landmarks Critical Care
Dr. Sherif Badrawy

17. IAP-SHOCK II ➜ Thiele 2012 ➜
lntraaortic balloon support in ACS
with early revascularization
〚Conclusion〛
8a
Landmarks Critical Care
Dr. Sherif Badrawy

18. ❀ In patients with acute coronary
syndromes and cardiogenic shock
with planned early revascularization,
the use of an intraaortic balloon
pump did not improve 30-day
mortality or tissue oxygenation.
8b
Landmarks Critical Care
Dr. Sherif Badrawy

19. MAPPET-3 ➜ Konstantinides 2002
➜ Alteplase with or without heparin
for submassive PE
〚Randomization〛
9a
Landmarks Critical Care
Dr. Sherif Badrawy

20. ❐ Randomized patients to alteplase
(10 mg IV bolus, then 90 mg over 2
hrs) or placebo. Both groups
received full anticoagulation with
unfractionated heparin
9b
Landmarks Critical Care
Dr. Sherif Badrawy

21. MAPPET-3 ➜ Konstantinides 2002
➜ Alteplase with or without heparin
for submassive PE
〚Conclusion〛
10a
Landmarks Critical Care
Dr. Sherif Badrawy

22. ❀ When given in conjunction with
heparin, alteplase can improve the clinical
course of stable patients who have acute
submassive pulmonary embolism and can
prevent clinical deterioration requiring the
escalation of treatment during the hospital
stay.
10b
Landmarks Critical Care
Dr. Sherif Badrawy

23. PROTECT ➜ PROTECT
Investigators 2011 ➜ Dalteparin vs.
unfractionated heparin for DVT
prophylaxis
〚Randomization〛
11a
Landmarks Critical Care
Dr. Sherif Badrawy

24. ❐ Randomized to dalteparin 5000
units daily or unfractionated
heparin (UFH) 5000 units Q 12h (Q
72h heparin may have been a weak
comparator- some favor
Q 8 h heparin)
11b
Landmarks Critical Care
Dr. Sherif Badrawy

25. PROTECT ➜ PROTECT
Investigators 2011 ➜ Dalteparin vs.
unfractionated heparin for DVT
prophylaxis
〚Conclusion〛
12a
Landmarks Critical Care
Dr. Sherif Badrawy

26. ❀ Dalteparin was comparable to
unfractionated heparin in preventing
proximal leg DVT. There were no
differences in clinical endpoints (length of
stay, mortality), but dalteparin was
associated with less pulmonary embolism.
12b
Landmarks Critical Care
Dr. Sherif Badrawy

27. SHOCK ➜ Hochman 1999 ➜ Early
revascularization versus medical
stabilization in cardiogenic shock
〚Randomization〛
13a
Landmarks Critical Care
Dr. Sherif Badrawy

28. ❐ Randomized patients to early
revascularization (anqioplasty or
bypass within 6 hours of
randomization) or medical
stabilization
13b
Landmarks Critical Care
Dr. Sherif Badrawy

29. SHOCK ➜ Hochman 1999 ➜ Early
revascularization versus medical
stabilization in cardiogenic shock
〚Conclusion〛
14a
Landmarks Critical Care
Dr. Sherif Badrawy

30. ❀ Compared to medical stabilization, emergent
revascularization in cardiogenic shock did not
improve 30-day mortality, but did confer a survival
benefit at six months.
❀ Early revascularization should be strongly
considered for patients with acute myocardial
infarction complicated by cardiogenic shock.
❀ The benefit of early revascularization was most
pronounced in younger patients with previous MI.
14b
Landmarks Critical Care
Dr. Sherif Badrawy

31. TROICA ➜ Bottiger 2009 ➜
Tenecteplase for OOH cardiac arrest
〚Randomization〛
15a
Landmarks Critical Care
Dr. Sherif Badrawy

32. ❐ Compared weight-based
tenecteplase (30-50 mg) vs. placebo
for 30-day survival
❐ Excluded patients with high
suspicion of PE
15b
Landmarks Critical Care
Dr. Sherif Badrawy

33. TROICA ➜ Bottiger 2009 ➜
Tenecteplase for OOH cardiac arrest
〚Conclusion〛
16a
Landmarks Critical Care
Dr. Sherif Badrawy

34. ❀ When tenecteplase was used without
adjunctive antithrombotic therapy during
advanced life support for out-of-hospital
cardiac arrest, we did not detect an
improvement in outcome, in comparison
with placebo.
16b
Landmarks Critical Care
Dr. Sherif Badrawy

35. 6S ➜ Perner 2012 ➜ HES vs. LR for
fluid resuscitation in severe sepsis
〚Randomization〛
17a
Landmarks Critical Care
Dr. Sherif Badrawy

36. ❐ Randomized to HES 130/0.42
(Tetraspan) or lactated ringers (LR)
as needed up to a maximum of 33
ml/kg/ day, after which open-label
LR was used
17b
Landmarks Critical Care
Dr. Sherif Badrawy

37. 6S ➜ Perner 2012 ➜ HES vs. LR for
fluid resuscitation in severe sepsis
〚Conclusion〛
18a
Landmarks Critical Care
Dr. Sherif Badrawy

38. ❀ For patients with severe sepsis,
hydroxyethyl starch (HES 130/0.42)
was associated with higher 90-day
mortality, need for renal eplacement
therapy, and the use of blood
products than lactated ringers (LR).
18b
Landmarks Critical Care
Dr. Sherif Badrawy

39. ALBIOS ➜ Caironi 2014 ➜ Daily
albumin replacement in severe
sepsis and septic shock
〚Randomization〛
19a
Landmarks Critical Care
Dr. Sherif Badrawy

40. ❐ Randomized patients to receive either
200-300 ml of 20% albumin daily for a
serum albumin level less than 3 g/dl or no
albumin replacement at all. Replacement
occurred for up to 28 days or untiiiCU
discharge. Both groups received
crystalloids when clinically indicated.
19b
Landmarks Critical Care
Dr. Sherif Badrawy

41. ALBIOS ➜ Caironi 2014 ➜ Daily
albumin replacement in severe
sepsis and septic shock
〚Conclusion〛
20a
Landmarks Critical Care
Dr. Sherif Badrawy

42. ❀ In patients with severe sepsis, daily
albumin replacement for low serum
albumin in addition to crystalloids,
as compared with crystalloids alone,
did not improve the rate of survival at
28 and 90 days.
20b
Landmarks Critical Care
Dr. Sherif Badrawy

43. ANNANE 2002 ➜ Hydrocortisone
therapy for septic shock
〚Randomization〛
21a
Landmarks Critical Care
Dr. Sherif Badrawy

44. ❐ Included 299 patients with septic shock and
mechanical ventilation within 3-8 hours of
meeting study criteria (CORTI GUS enrolled
within 72 hours
❐ Compared placebo vs. hydrocortisone 50 mg
IV Q 6h + fludrocortisone 50 meg PO daily x 7
days (no taper)
21b
Landmarks Critical Care
Dr. Sherif Badrawy

45. ANNANE 2002 ➜ Hydrocortisone
therapy for septic shock
〚Conclusion〛
22a
Landmarks Critical Care
Dr. Sherif Badrawy

46. ❀ Among patients with very early septic shock
who were non-responders to a Cosyntropin stim
test, hydrocortisone / fludrocortisone therapy
improved 28-day survival. Furthermore, steroid
therapy reduced duration of vasopressor therapy
the risk of death in patients with septic shock and
relative adrenal insufficiency without increasing
adverse events.(regardless of stim test response).
22b
Landmarks Critical Care
Dr. Sherif Badrawy

47. CHEST ➜ Myburgh 2012 ➜ HES vs.
saline for fluid resuscitation
〚Randomization〛
23a
Landmarks Critical Care
Dr. Sherif Badrawy

48. ❐ Randomized to 6% HES 130/0.4 (Voluven) or
0.9% normal saline for the duration of the
patient's ICU stay. In patients requiring more
than 50 ml/kg/ day, open-label saline was used
❐ Excluded patients with dialysisdependent renal
failure or intracranial hemorrhage
23b
Landmarks Critical Care
Dr. Sherif Badrawy

49. CHEST ➜ Myburgh 2012 ➜ HES vs.
saline for fluid resuscitation
〚Conclusion〛
24a
Landmarks Critical Care
Dr. Sherif Badrawy

50. ❀ For ICU patients requiring fluid
resuscitation, hydroxyethyl starch (HES
130/0.4) was equivalent to normal saline
in 90-day mortality, but HES increased
the risk of renal failure and the need for
blood products.
24b
Landmarks Critical Care
Dr. Sherif Badrawy

51. CORTICUS ➜ Sprung 2008 ➜
Hydrocortisone therapy for septic
shock
〚Randomization〛
25a
Landmarks Critical Care
Dr. Sherif Badrawy

52. ❐ Included 499 patients with septic shock
within the past 72 hours. (Annane 2002
enrolled patients within 8 hours of shock)
❐ Randomized patients to placebo or
hydrocortisone (without fludrocortisone)
25b
Landmarks Critical Care
Dr. Sherif Badrawy

53. CORTICUS ➜ Sprung 2008 ➜
Hydrocortisone therapy for septic
shock
〚Conclusion〛
26a
Landmarks Critical Care
Dr. Sherif Badrawy

54. ❀ Hydrocortisone therapy did not
improve outcomes among patients with
septic shock (onset within 72 hours),
although it did shorten the duration of
vasopressor dependence.(hastened
reversal of shock in patients in whom
shock was reversed).
26b
Landmarks Critical Care
Dr. Sherif Badrawy

55. CRISTAL ➜ Annane2013 ➜ Colloids
versus crystalloids for ICU
hypovolemia
〚Randomization〛
27a
Landmarks Critical Care
Dr. Sherif Badrawy

56. ❐ Randomized patients to crystalloids or colloids.
Investigators were non-blinded and allowed to select from a
variety of fluid options. In the crystalloid group,
normal saline was used in 85% of cases and Ringers lactate
in 18%. In the colloid group, hydroxyethyl starch was used
in 69% of patients, gelatins in 35%, albumin- 4% in 6%, and
albumin-20% in 14%. The dose of fluid was also at the
discretion of the unblinded investigator.
27b
Landmarks Critical Care
Dr. Sherif Badrawy

57. CRISTAL ➜ Annane2013 ➜ Colloids
versus crystalloids for ICU
hypovolemia
〚Conclusion〛
28a
Landmarks Critical Care
Dr. Sherif Badrawy

58. ❀ In a heterogeneous ICU population with
hypovolemia, there was no difference in 28- day
mortality between crystalloids and colloids.
❀ Colloids did demonstrate benefit in duration of
mechanical ventilation, vasopressor use, and 90-
day mortality, although these were secondary
endpoints that are conflicting with previous
literature and deserve further study.
28b
Landmarks Critical Care
Dr. Sherif Badrawy

59. DRAKULOVIC 1999 ➜ Semi
recumbent position for mechancial
ventilation
〚Randomization〛
29a
Landmarks Critical Care
Dr. Sherif Badrawy

60. ❐ Randomized patients to semi recumbent
(45° head of bed) or supine (0°)
❐ Excluded recent abdominal surgery,
neurosurgery, shock refractory to
vasoactive therapy, and previous
intubation in the past 30 days
29b
Landmarks Critical Care
Dr. Sherif Badrawy

61. DRAKULOVIC 1999 ➜ Semi
recumbent position for mechancial
ventilation
〚Conclusion〛
30a
Landmarks Critical Care
Dr. Sherif Badrawy

62. ❀ The semirecumbent body position
reduces frequency and risk of nosocomial
pneumonia, especially in patients who
receive enteral nutrition. The risk of
nosocomial pneumonia is increased by
longduration mechanical ventilation and
decreased consciousness.
30b
Landmarks Critical Care
Dr. Sherif Badrawy

63. EPaNIC ➜ Casaer 2011 ➜ Early vs.
late parenteral
nutrition
〚Randomization〛
31a
Landmarks Critical Care
Dr. Sherif Badrawy

64. ❐ Randomized patients to early or late parenteral
nutrition. Early nutrition consisted of 20% dextrose
for 2 days, then full TPN. Late nutrition consisted of
5% dextrose for 7 days, then full TPN. In both groups,
TPN was reduced or stopped based on enteral
nutrition intake
❐ Excluded those taking oral nutrition and BMI < 17
31b
Landmarks Critical Care
Dr. Sherif Badrawy

65. EPaNIC ➜ Casaer 2011 ➜ Early vs.
late parenteral
nutrition
〚Conclusion〛
32a
Landmarks Critical Care
Dr. Sherif Badrawy

66. ❀ Early initiation of TPN increased ICU and
hospital stay, the incidence of infection, and total
healthcare costs. Delaying parenteral nutrition
up to 7 days had no effect on mortality.
❀ [Late initiation of parenteral nutrition was
associated with faster recovery and fewer
complications, as compared with early
initiation].
32b
Landmarks Critical Care
Dr. Sherif Badrawy

67. JONES 2010 ➜ Lactate clearance
vs. Scv02 for Early Goal-Directed
Therapy
〚Randomization〛
33a
Landmarks Critical Care
Dr. Sherif Badrawy

68. ❐ Randomized patients to either central
venous oxygen saturation (Scv02 > 70%)
or lactate clearance (> 1 0% clearance).
This was the third goal of therapy
following maximization of central venous
pressure (CVP > 8 mmHg) and mean
arterial pressure (MAP > 65 mmHg)
33b
Landmarks Critical Care
Dr. Sherif Badrawy

69. JONES 2010 ➜ Lactate clearance
vs. Scv02 for Early Goal-Directed
Therapy
〚Conclusion〛
34a
Landmarks Critical Care
Dr. Sherif Badrawy

70. ❀ Among patients with septic shock who were
treated to normalize central venous and mean
arterial pressure, additional management to
normalize lactate clearance compared with
management to normalize Scv02 did not result in
significantly different in-hospital mortality.
❀ lactate clearance is non-inferior to central
venous oxygen saturation for hospital mortality.
34b
Landmarks Critical Care
Dr. Sherif Badrawy

71. PROWESS ➜ Bernard 2001 ➜
Xigris for severe sepsis
〚Randomization〛
35a
Landmarks Critical Care
Dr. Sherif Badrawy

72. ❐ Included 1690 patients with severe
sepsis or septic shock within 24 hours
❐ Randomized to receive drotrecogin
alfa (DrotAA) 24 mcg/kg/hr or
placebo x 96 hrs
35b
Landmarks Critical Care
Dr. Sherif Badrawy

73. PROWESS ➜ Bernard 2001 ➜
Xigris for severe sepsis
〚Conclusion〛
36a
Landmarks Critical Care
Dr. Sherif Badrawy

74. ❀ Drotrecogin alfa improved mortality
among patients with severe sepsis or septic
shock, particularly those with a high
APACHE II score,and may be associated
with an increased risk of bleeding. but
subsequent trials have failed to show a
similar mortality benefit.
36b
Landmarks Critical Care
Dr. Sherif Badrawy

75. PROWESS-SHOCK ➜ Ranieri 2012
➜ Xigris for septic shock
〚Randomization〛
37a
Landmarks Critical Care
Dr. Sherif Badrawy

76. ❐ Included 1697 patients with septic shock
(requiring 4+ hrs of vasopressors) and clinical
evidence of hypoperfusion (metabolic acidosis,
renal or hepatic dysfunction).
❐ Randomized to receive drotrecogin alfa
(DrotAA) 24 mcg/kg/hr or placebo x 96 hrs
37b
Landmarks Critical Care
Dr. Sherif Badrawy

77. PROWESS-SHOCK ➜ Ranieri 2012
➜ Xigris for septic shock
〚Conclusion〛
38a
Landmarks Critical Care
Dr. Sherif Badrawy

78. ❀ Drotrecogin alta did not improve
28-day or
90-day mortality compared to
placebo in patients with septic shock
38b
Landmarks Critical Care
Dr. Sherif Badrawy

79. ProCESS ➜ The ProCESS
Investigators 2014 ➜ Protocol-
Based Care for Early Septic Shock
〚Randomization〛
39a
Landmarks Critical Care
Dr. Sherif Badrawy

80. ❐ Randomized patients in a 1:1:1
ratio to protocolized early goal
directed therapy(EGDT),
protocolized standard- therapy, or
usual-care
39b
Landmarks Critical Care
Dr. Sherif Badrawy

81. ProCESS ➜ The ProCESS
Investigators 2014 ➜ Protocol-
Based Care for Early Septic Shock
〚Conclusion〛
40a
Landmarks Critical Care
Dr. Sherif Badrawy

82. ❀ Traditional early goal-directed
therapy, a new protocolized
standard-therapy, and a no-protocol
usual-therapy approach were all
equally effective in treating early
septic shock patients.
40b
Landmarks Critical Care
Dr. Sherif Badrawy

83. RIVERS 2001 ➜ Early goal-directed
therapy for
severe sepsis and septic shock
〚Randomization〛
41a
Landmarks Critical Care
Dr. Sherif Badrawy

84. ❐ Randomized patients to standard
of care vs. protocolized early goal-
directed therapy (EGDT) prior to ICU
admission. ED team was not blinded,
but accepting ICU team was blinded
to treatment assignment
41b
Landmarks Critical Care
Dr. Sherif Badrawy

85. RIVERS 2001 ➜ Early goal-directed
therapy for
severe sepsis and septic shock
〚Conclusion〛
42a
Landmarks Critical Care
Dr. Sherif Badrawy

86. ❀ Protocolized early goal-directed
therapy initiated in the ED in severe
sepsis and septic shock patients
improved resuscitation parameters
and reduced mortality.
42b
Landmarks Critical Care
Dr. Sherif Badrawy

87. SAFE ➜ Finfer 2004 ➜ Albumin vs.
saline for fluid resuscitation
〚Randomization〛
43a
Landmarks Critical Care
Dr. Sherif Badrawy

88. ❐ Randomized patients to receive doubleblinded
4% albumin or normal saline 500 ml boluses. All
other aspects of ICU care were left to the
discretion of the treating clinician
❐ Excluded post-op cardiac surgery, liver
transplantation, and burns
43b
Landmarks Critical Care
Dr. Sherif Badrawy

89. SAFE ➜ Finfer 2004 ➜ Albumin vs.
saline for fluid resuscitation
〚Conclusion〛
44a
Landmarks Critical Care
Dr. Sherif Badrawy

90. ❀ For all ICU patients requiring fluid resuscitation,
albumin was equivalent to normal saline in 28-day
mortality .Hypothesis-generating subgroup analysis
indicated that trauma patients may benefit from
normal saline whereas septic shock patients may
benefit from albumin.
❀ use of either 4 percent albumin or normal saline
for fluid resuscitation results in similar outcomes at
28 days.
44b
Landmarks Critical Care
Dr. Sherif Badrawy

91. SEPSISPAM ➜ Asfar 2014 ➜ High
versus low MAP goal in septic shock
〚Randomization〛
45a
Landmarks Critical Care
Dr. Sherif Badrawy

92. ❐ Randomized patients to high-
target (MAP goal 80-85 mmHg) or
low-target (MAP 65-70 mmHg) for
up to 5 days
45b
Landmarks Critical Care
Dr. Sherif Badrawy

93. SEPSISPAM ➜ Asfar 2014 ➜ High
versus low MAP goal in septic shock
〚Conclusion〛
46a
Landmarks Critical Care
Dr. Sherif Badrawy

94. ❀ In patients with septic shock, a higher MAP goal did not
reduce mortality but did increase the risk of atrial
fibrillation. In a pre-specified subgroup of patients with a
history of hypertension, a higher MAP goal was associated
with a reduction in the need for RRT.
❀ MAP of 80 to 85 mm Hg, as compared with 65 to 70
mm Hg, in patients with septic shock undergoing
resuscitation did not result in significant differences in
mortality at either 28 or 90 days.
46b
Landmarks Critical Care
Dr. Sherif Badrawy

95. SIC ➜ Angstwurm 2007 ➜
Selenium in intensive care
〚Randomization〛
47a
Landmarks Critical Care
Dr. Sherif Badrawy

96. ❐ Randomized patients to sodium-
selenite 1000 meg bolus, then 1000
meg/day (2 ml/hr) continuous
infusion for 14 days (total of 6.9 mg
elemental selenium) or placebo (48
ml normal saline per day)
47b
Landmarks Critical Care
Dr. Sherif Badrawy

97. SIC ➜ Angstwurm 2007 ➜
Selenium in intensive care
〚Conclusion〛
48a
Landmarks Critical Care
Dr. Sherif Badrawy

98. ❀ Selenium supplementation was
not associated with a decrease in
mortality among a heterogeneous
ICU population with SlRS criteria;
however, a favorable
trend was noted
48b
Landmarks Critical Care
Dr. Sherif Badrawy

99. SOAPII ➜ De Backer 2010 ➜
Dopamine vs Norepinephrine for
shock
〚Randomization〛
49a
Landmarks Critical Care
Dr. Sherif Badrawy

100. ❐ Randomized to dopamine
(titrated by 2 meg/kg/min to max
20 meg/kg/min) or norepinephrine
(titrated by 0.02 meg/kg/min to
max 0.1 9 meg/kg/min -- 1 5 meg/
min for 80 kg patient)
49b
Landmarks Critical Care
Dr. Sherif Badrawy

101. SOAPII ➜ De Backer 2010 ➜
Dopamine vs Norepinephrine for
shock
〚Conclusion〛
50a
Landmarks Critical Care
Dr. Sherif Badrawy

102. ❀ Among patients with all types of shock,
mortality rates were not different between
norepinephrine and dopamine, although
norepinephrine was more effective as a
vasopressor and was less associated with
arrhythmias. Norepinephrine may have a
mortality benefit over dopamine in a subset of
patients with cardiogenic shock.
50b
Landmarks Critical Care
Dr. Sherif Badrawy

103. TRICC ➜ Hebert 1999 ➜ Restrictive
vs. liberal blood transfusion in the
ICU
〚Randomization〛
51a
Landmarks Critical Care
Dr. Sherif Badrawy

104. ❐ Compared a conservative transfusion
strategy (goal Hgb 7-9 g/dL) vs. liberal
strategy (goal 10-12 g/dL)
❐ Excluded patients with active blood loss
and chronic anemia (Hgb < 9 g/dl more
than one month prior to admission)
51b
Landmarks Critical Care
Dr. Sherif Badrawy

105. TRICC ➜ Hebert 1999 ➜ Restrictive
vs. liberal blood transfusion in the
ICU
〚Conclusion〛
52a
Landmarks Critical Care
Dr. Sherif Badrawy

106. ❀ Compared to a liberal transfusion
strategy, a conservative transfusion strategy
had no impact on mortality, but did result in
a reduction in RBC transfusions and fewer
cardiac events with the possible exception of
patients with acute myocardial infarction
and unstable angina
52b
Landmarks Critical Care
Dr. Sherif Badrawy

107. VASST ➜ Russell 2008 ➜
Vasopressin vs additional
norepinephrine for septic shock
〚Randomization〛
53a
Landmarks Critical Care
Dr. Sherif Badrawy

108. ❐ Randomized to additional
norepinephrine (5-15 meg/min) or
vasopressin (0.01- 0.03 units/min)
53b
Landmarks Critical Care
Dr. Sherif Badrawy

109. VASST ➜ Russell 2008 ➜
Vasopressin vs additional
norepinephrine for septic shock
〚Conclusion〛
54a
Landmarks Critical Care
Dr. Sherif Badrawy

110. ❀ Vasopressin was comparable to
additional norepinephrine among septic
shock patients receiving norepinephrine.
❀ Vasopressin may provide some
mortality benefit in a subgroup of patients
with less severe vasopressor requirements.
54b
Landmarks Critical Care
Dr. Sherif Badrawy

111. VILLANUEVA 2013 ➜ Restrictive
vs. liberal blood
transfusion in upper Gl bleed
〚Randomization〛
55a
Landmarks Critical Care
Dr. Sherif Badrawy

112. ❐ Randomized patients to a transfusion threshold
of restrictive (7 g/dL) or liberal (9 g/dL)
❐ Excluded massive exsanguinating bleeding, ACS,
symptomatic peripheral vasculopathy, stroke/TIA,
transfusion in past 90 days, recent trauma or
surgery, lower Gl bleed, or Rockall score of 0 with
a hemoglobin > 12 g/dl
55b
Landmarks Critical Care
Dr. Sherif Badrawy

113. VILLANUEVA 2013 ➜ Restrictive
vs. liberal blood
transfusion in upper Gl bleed
〚Conclusion〛
56a
Landmarks Critical Care
Dr. Sherif Badrawy

114. ❀ In patients with an upper Gl
bleed,a restrictive transfusion
strategy reduced mortality and
resulted in fewer RBC transfusions
compared to a liberal transfusion
strategy.
56b
Landmarks Critical Care
Dr. Sherif Badrawy

115. COIITSS ➜ COIITSS Investigators
2010 ➜ Corticosteroids and
intensive insulin for septic shock
〚Randomization〛
57a
Landmarks Critical Care
Dr. Sherif Badrawy

116. ❐ Randomized patients to receive
conventional (<150 mg/dL) vs.
intensive (80-11 0 mg/dL) glucose
control and
fludrocortisone 50 meg PO daily vs.
placebo x 7 days
57b
Landmarks Critical Care
Dr. Sherif Badrawy

117. COIITSS ➜ COIITSS Investigators
2010 ➜ Corticosteroids and
intensive insulin for septic shock
〚Conclusion〛
58a
Landmarks Critical Care
Dr. Sherif Badrawy

118. ❀ Among patients with septic shock receiving
Hydrocortisone, neither intensive glucose control
nor fludrocortisone improved mortality.
Intensive glucose
control was associated with a higher incidence of
hypoglycemia and fludrocortisone with a higher
incidence of new infections.
58b
Landmarks Critical Care
Dr. Sherif Badrawy

119. LEUVEN I ➜ van den Berghe 2002
➜ Intensive insulin therapy in the
SICU
〚Randomization〛
59a
Landmarks Critical Care
Dr. Sherif Badrawy

120. ❐ Randomized patients to intensive
insulin (BG goal 80-11 0 mg/dL) or
conventional insulin (BG < 215
mg/dL)
59b
Landmarks Critical Care
Dr. Sherif Badrawy

121. LEUVEN I ➜ van den Berghe 2002
➜ Intensive insulin therapy in the
SICU
〚Conclusion〛
60a
Landmarks Critical Care
Dr. Sherif Badrawy

122. ❀ In surgical ICU patients (primarily
cardiac), intensive insulin therapy reduced
ICU mortality, renal impairment, and
bloodstream infections. The rate of severe
hypoglycemia was higher with intensive
insulin.
60b
Landmarks Critical Care
Dr. Sherif Badrawy

123. LEUVEN II ➜ Intensive insulin
therapy in the MICU
〚Randomization〛
61a
Landmarks Critical Care
Dr. Sherif Badrawy

124. ❐ Randomized patients to intensive
insulin (BG goal 80-110 mg/dL) or
conventional insulin (BG < 215 mg/dL)
❐ Excluded all surgical patients and those
able to receive oral nutrition
61b
Landmarks Critical Care
Dr. Sherif Badrawy

125. LEUVEN II ➜ Intensive insulin
therapy in the MICU
〚Conclusion〛
62a
Landmarks Critical Care
Dr. Sherif Badrawy

126. ❀ In patients in the medical ICU, intensive
insulin therapy did not improve mortality.
While intensive therapy may have had a
positive effect on duration of mechanical
ventilation and length of ICU stay, it was
associated with a higher incidence of
severe hypoglycemia.
62b
Landmarks Critical Care
Dr. Sherif Badrawy

127. NICE-SUGAR ➜ Intensive insulin
therapy in the MICU/SICU
〚Randomization〛
63a
Landmarks Critical Care
Dr. Sherif Badrawy

128. ❐ Randomized patients to intensive
control (BG 81-108 mg/dL) vs.
conventional control (<180 mg/dL)
63b
Landmarks Critical Care
Dr. Sherif Badrawy

129. NICE-SUGAR ➜ Intensive insulin
therapy in the MICU/SICU
〚Conclusion〛
64a
Landmarks Critical Care
Dr. Sherif Badrawy

130. ❀ Among critically ill patients, intensive glucose
control increased 90-day mortality and the
incidence of severe hypoglycemia compared to
conventional therapy.
❀ a blood glucose target of 180 mg or less per
deciliter resulted in lower mortality than did a
target of 81 to 108 mg per deciliter.
64b
Landmarks Critical Care
Dr. Sherif Badrawy

131. VISEP ➜ Brunkhorst 2008 ➜
Intensive insulin and
pentastarch in severe
sepsis〚Randomization〛
65a
Landmarks Critical Care
Dr. Sherif Badrawy

132. ❐ Randomized patients to intensive
or conventional
glycemic control and either
pentastarch or lactated ringer's (LR)
for 21 days or until ICU discharge.
65b
Landmarks Critical Care
Dr. Sherif Badrawy

133. VISEP ➜ Brunkhorst 2008 ➜
Intensive insulin and pentastarch in
severe sepsis〚Conclusion〛
66a
Landmarks Critical Care
Dr. Sherif Badrawy

134. ❀ In patients with severe sepsis or septic shock
,intensive insulin therapy was associated with a
very high hypoglycemia rate without a mortality
benefit .
Additionally, pentastarch (HES 200/0.5) causes
renal impairment and may have a dose-
dependent detrimental effect on 90-day
mortality.
66b
Landmarks Critical Care
Dr. Sherif Badrawy

135. ANDIRUILLI 2008 ➜ High vs.
standard-dose PPI for upper Gl
bleeding ulcer〚Randomization〛
67a
Landmarks Critical Care
Dr. Sherif Badrawy

136. ❐ Randomized patients to omeprazo e or pantoprazole IV
(based on investigator preference) at either "high-dose" (80
mg bolus, then 8 mg/hr x 72 hours) or "standard-dose" (40
mg once daily). Both groups switched to an oral PPI after 72
hours (20 mg PO BID)
❐ Excluded severe coagulopathy (platelet < 100,000 or INR
> 1.5) and those receiving PPI therapy before index
endoscopy
67b
Landmarks Critical Care
Dr. Sherif Badrawy

137. ANDIRUILLI 2008 ➜ High vs.
standard-dose PPI for upper Gl
bleeding ulcer〚Conclusion〛
68a
Landmarks Critical Care
Dr. Sherif Badrawy

138. ❀ In patients with an upper Gl bleeding
ulcer and successful endoscopic
treatment,a standard-dose IV PPI used
significantly less drug and did not result in
different rebleeding rates compared to a
high-dose infusion.
68b
Landmarks Critical Care
Dr. Sherif Badrawy

139. BESSON 1995 ➜ Octreotide for
acute variceal bleeding
〚Randomization〛
69a
Landmarks Critical Care
Dr. Sherif Badrawy

140. ❐ Randomized patients to
octreotide 25 mcg/hr or placebo for
five total days
69b
Landmarks Critical Care
Dr. Sherif Badrawy

141. BESSON 1995 ➜ Octreotide for
acute variceal bleeding
〚Conclusion〛
70a
Landmarks Critical Care
Dr. Sherif Badrawy

142. ❀ In patients with variceal
hemorrhage, sclerotherapy with
octreotide is more effective in
reducing rebleeding rates (but not
mortality) compared to
sclerotherapy alone.
70b
Landmarks Critical Care
Dr. Sherif Badrawy

143. LAU 2000 ➜ PPI drip for upper Gl
bleeding ulcer 〚Randomization〛
71a
Landmarks Critical Care
Dr. Sherif Badrawy

144. ❐ Randomized patients to placebo or
omeprazole (80 mg bolus, then 8 mg/hr x
72 hours) following endoscopy.
❐ All patients received omeprazole 20 mg
PO daily x 8 weeks following the 72 hour
study period
71b
Landmarks Critical Care
Dr. Sherif Badrawy

145. LAU 2000 ➜ PPI drip for upper Gl
bleeding ulcer 〚Conclusion〛
72a
Landmarks Critical Care
Dr. Sherif Badrawy

146. ❀ In patients with an upper Gl
bleeding ulcer, a high-dose
omeprazole infusion reduced
recurrent bleeding compared to
placebo following successful
endoscopic treatment.
72b
Landmarks Critical Care
Dr. Sherif Badrawy

147. BERNARD 2002 ➜ Australian
hypothermia study
for out-of-hospital
arrest〚Randomization〛
73a
Landmarks Critical Care
Dr. Sherif Badrawy

148. ❐ Randomized patients to
therapeutic hypothermia (33°C) or
normothermia x 12 hrs. Both patient
groups received midazolam and
vecuronium
73b
Landmarks Critical Care
Dr. Sherif Badrawy

149. BERNARD 2002 ➜ Australian
hypothermia study
for out-of-hospital
arrest〚Conclusion〛
74a
Landmarks Critical Care
Dr. Sherif Badrawy

150. ❀ Therapeutic hypothermia in
patients with out-of-hospital VF
arrest improved the incidence of
favorable discharge disposition and
a trend towards improved mortality.
74b
Landmarks Critical Care
Dr. Sherif Badrawy

151. HACA ➜ HACA Study Group 2002
European hypothermia study for
out-of-hospital
arrest〚Randomization〛
75a
Landmarks Critical Care
Dr. Sherif Badrawy

152. ❐ Randomized patients to receive normothermia or
hypothermia (32-34°C) with cool air blanket with or
without ice packs x 24 hours, and then rewarmed
over 8 hours.
❐ Excluded patients responding to verbal commands
post-arrest, known preexisting coagulopathy
75b
Landmarks Critical Care
Dr. Sherif Badrawy

153. HACA ➜ HACA Study Group 2002
European hypothermia study for
out-of-hospital
arrest〚Conclusion〛
76a
Landmarks Critical Care
Dr. Sherif Badrawy

154. ❀ Therapeutic hypothermia improved 6-
month neurologic outcome and mortality
among patients with out-of-hospital VT
/VF cardiac arrest. Note that hypothermia
may be associated with certain
complications, such as increased risk of
bleeding and infection.
76b
Landmarks Critical Care
Dr. Sherif Badrawy

155. TTM ➜ Nielsen 2013 ➜ Therapeutic
hypothermia with 33°C versus
36°C〚Randomization〛
77a
Landmarks Critical Care
Dr. Sherif Badrawy

156. ❐ Randomized patients to 33°C or 36°C using chilled fluids,
ice packs, and surface or intravascular cooling for 28 hours.
After the cooling period, both patient groups were
rewarmed at 0.5°C per hour to a temperature of 37°C
❐ Excluded those with unwitnessed arrest with asystole,
more than 240 minutes between return of spontaneous
circulation and trial screening, intracranial hemorrhage or
stroke, and body temperature < 30°C
77b
Landmarks Critical Care
Dr. Sherif Badrawy

157. TTM ➜ Nielsen 2013 ➜ Therapeutic
hypothermia with 33°C versus
36°C〚Conclusion〛
78a
Landmarks Critical Care
Dr. Sherif Badrawy

158. ❀ In patients with out-of-hospital
cardiac arrest with return of
spontaneous circulation, there was
no difference in longterm mortality
between therapeutic hypothermia
with 36°C and 33°C.
78b
Landmarks Critical Care
Dr. Sherif Badrawy

159. BOZZETTE 1990 ➜ Adjunct
corticosteroids for PJP
〚Randomization〛
79a
Landmarks Critical Care
Dr. Sherif Badrawy

160. ❐ Randomized patients to
prednisone (40 mg BID x 5 days, 40
mg daily x 5 days, 20 mg daily for
duration of antibiotic therapy
[typically 14-21 days]) or placebo
79b
Landmarks Critical Care
Dr. Sherif Badrawy

161. BOZZETTE 1990 ➜ Adjunct
corticosteroids for PJP
〚Conclusion〛
80a
Landmarks Critical Care
Dr. Sherif Badrawy

162. ❀ Adjunctive corticosteroids in patients with
AIDS and pneumocystis pneumonia improved
mortality and respiratory failure among patients
with moderate-to-severe pneumonia, although
steroid therapy increased the risk of herpes
reactivation and oral thrush.
80b
Landmarks Critical Care
Dr. Sherif Badrawy

163. CHASTER 2003 ➜ 8 vs. 1 5 days of
antibiotics for VAP
〚Randomization〛
81a
Landmarks Critical Care
Dr. Sherif Badrawy

164. ❐ Randomized patients to receive 8
days or 15 days of appropriate
antibiotic therapy
81b
Landmarks Critical Care
Dr. Sherif Badrawy

165. CHASTER 2003 ➜ 8 vs. 1 5 days of
antibiotics for VAP
〚Conclusion〛
82a
Landmarks Critical Care
Dr. Sherif Badrawy

166. ❀ Among patients with late-onset VAP or early-
onset VAP with recent antibiotic exposure, 8-
days was non-inferior to 15- days of appropriate
antibiotic therapy for mortality and pneumonia
recurrence. In patients with certain non-
fermenting gram negatives, a 15-day course may
be more appropriate.
82b
Landmarks Critical Care
Dr. Sherif Badrawy

167. KUMAR 2006 ➜ Delay in
antibiotics increases
septic shock
mortality〚Randomization〛
83a
Landmarks Critical Care
Dr. Sherif Badrawy

168. ❐ Retrospective cohort of 2,731
septic shock patients from the US
and Canada
❐ Onset of hypotension to first
appropriate antibiotic very delayed
(median 6 hrs, mean 13.5 hrs)
83b
Landmarks Critical Care
Dr. Sherif Badrawy

169. KUMAR 2006 ➜ Delay in
antibiotics increases
septic shock
mortality〚Conclusion〛
84a
Landmarks Critical Care
Dr. Sherif Badrawy

170. ❀ Effective antimicrobial administration within the
first hour of documented hypotension was associated
with increased survival to hospital discharge in adult
patients with septic shock. Despite a progressive
increase in mortality rate with increasing delays, only
50% of septic shock patients received effective
antimicrobial therapy within 6 hrs of documented
hypotension.[7.6% increase in mortality/ hour]
84b
Landmarks Critical Care
Dr. Sherif Badrawy

171. PROTRATA ➜ Bouadma 2010 ➜
Procalcitonin algorithm for guiding
antibiotic
therapy〚Randomization〛
85a
Landmarks Critical Care
Dr. Sherif Badrawy

172. ❐ Randomized to procalcitonin (PCT) or
control groups in an open-label design
❐ Excluded patients who were
immunosuppressed or those with
infections requiring a long-term duration
of treatment (ie, endocarditis)
85b
Landmarks Critical Care
Dr. Sherif Badrawy

173. PROTRATA ➜ Bouadma 2010 ➜
Procalcitonin algorithm for guiding
antibiotic therapy〚Conclusion〛
86a
Landmarks Critical Care
Dr. Sherif Badrawy

174. ❀ Use of a procalcitonin-guided
algorithm for suspected bacterial
infections reduced antibiotic
exposure but did not directly
improve patient outcomes.
86b
Landmarks Critical Care
Dr. Sherif Badrawy

175. SORT 1999 ➜ Albumin for
spontaneous bacterial
peritonitis〚Randomization〛
87a
Landmarks Critical Care
Dr. Sherif Badrawy

176. ❐ Randomized to
cefotaxime/placebo or Cefotaxime/
albumin. Albumin 20% was given as
1.5 gm/kg at enrollment and 1
gm/kg on day 3
87b
Landmarks Critical Care
Dr. Sherif Badrawy

177. SORT 1999 ➜ Albumin for
spontaneous bacterial
peritonitis〚Conclusion〛
88a
Landmarks Critical Care
Dr. Sherif Badrawy

178. ❀ Two doses of concentrated
albumin in patients with
spontaneous bacterial peritonitis
reduced renal impairment and
mortality compared to placebo.
88b
Landmarks Critical Care
Dr. Sherif Badrawy

179. Wunderink 2003 ➜ Linezolid vs
Vancomycin for HAP
〚Randomization〛
89a
Landmarks Critical Care
Dr. Sherif Badrawy

180. ❐ Compared linezolid 600 mg IV
Q12h vs. vancomycin 1 g IV Q12h
(adjusted to local institution's
standard of care) x 7-21 days. Both
study groups received aztreonam 1-
2g IV Q8h
89b
Landmarks Critical Care
Dr. Sherif Badrawy

181. Wunderink 2003 ➜ Linezolid vs
Vancomycin for HAP
〚Conclusion〛
90a
Landmarks Critical Care
Dr. Sherif Badrawy

182. ❀ In patients with HAP or VAP, linezolid
was associated with higher 28-day survival
compared to vancomycin in pts with
MRSA pneumonia. This survival benefit
was not seen in the entire trial cohort or
even in the S. au reus cohort.
90b
Landmarks Critical Care
Dr. Sherif Badrawy

183. Wunderink 2012 ➜ Linezolid vs.
vancomycin for
MRSA HAP〚Randomization〛
91a
Landmarks Critical Care
Dr. Sherif Badrawy

184. ❐ Randomized patients to linezolid
600 mg IV Q12h vs. vancomycin 15
mg/kg Q12h (dosing adjusted by a
local pharmacist) for 7-14 days (21
days if concurrent
bacteremia)
91b
Landmarks Critical Care
Dr. Sherif Badrawy

185. Wunderink 2012 ➜ Linezolid vs.
vancomycin for
MRSA HAP〚Conclusion〛
92a
Landmarks Critical Care
Dr. Sherif Badrawy

186. ❀ In a cohort of patients with MRSA pneumonia,
linezolid was shown to improve clinical cure rate
and cause less nephrotoxicity than vancomycin,
but it did not improve 60-day mortality. The
findings of this study may have been confounded
by unbalanced baseline characteristics.
92b
Landmarks Critical Care
Dr. Sherif Badrawy

187. de Gans 2002 ➜ Dexamethasone for
adult bacterial
meningitis〚Randomization〛
93a
Landmarks Critical Care
Dr. Sherif Badrawy

188. ❐ Randomized patients to receive
dexamethasone 1 0 mg IV Q 6h or
placebo x 4 days. Treatment was
started 0-20 minutes PRIOR to
antibiotic administration
93b
Landmarks Critical Care
Dr. Sherif Badrawy

189. de Gans 2002 ➜ Dexamethasone for
adult bacterial
meningitis〚Conclusion〛
94a
Landmarks Critical Care
Dr. Sherif Badrawy

190. ❀ Early, empiric treatment with
dexamethasone in patients with suspected
meningitis improved discharge outcome
and mortality, but this effect was only seen
among patients with confirmed
S.pneumoniae meningitis.
94b
Landmarks Critical Care
Dr. Sherif Badrawy

191. ABC ➜ Awake and breathing
trial〚Randomization〛
95a
Landmarks Critical Care
Dr. Sherif Badrawy

192. ❐ Randomized patients to
intervention (SAT +SBT) or control
(SBT alone)
95b
Landmarks Critical Care
Dr. Sherif Badrawy

193. ABC ➜ Awake and breathing
trial〚Conclusion〛
96a
Landmarks Critical Care
Dr. Sherif Badrawy

194. ❀ A sedation awakening trial (SAT) and a
spontaneous breathing trial (SBT) used together
were superior to SBT alone for reducing duration
of mechanical ventilation and 90-day mortality.
The combination of SAT +SBT was associated
with more self extubation, but not more
reintubation following self-extubation.
96b
Landmarks Critical Care
Dr. Sherif Badrawy

195. Kress 2000 ➜ Daily interruption of
sedative infusions
〚Randomization〛
97a
Landmarks Critical Care
Dr. Sherif Badrawy

196. ❐ All patients received morphine
infusions for analgesia, randomized
to either midazolam or propofol
infusions for sedation, and again
randomized to either "daily
interruption" or standard of care
97b
Landmarks Critical Care
Dr. Sherif Badrawy

197. Kress 2000 ➜ Daily interruption of
sedative infusions
〚Conclusion〛
98a
Landmarks Critical Care
Dr. Sherif Badrawy

198. ❀ Medical ICU patients receiving
continuous infusion sedation with daily
interruption were liberated from
mechanical ventilation and left the ICU
quicker, but this effect did not translate to
a shorter hospital course or a mortality
benefit.
98b
Landmarks Critical Care
Dr. Sherif Badrawy

199. MENDS ➜ Pandharipande 2007 ➜
Dexmedetomidine vs lorazepam
〚Randomization〛
99a
Landmarks Critical Care
Dr. Sherif Badrawy

200. ❐ Randomized patients to
dexmedetomidine (0.15 to 1.5
meg/kg/ hr) or lorazepam (1 to 1 0
mg/hr) until extubation or up to 5
days. Bolus dosing was not allowed
99b
Landmarks Critical Care
Dr. Sherif Badrawy

201. MENDS ➜ Pandharipande 2007 ➜
Dexmedetomidine vs lorazepam
〚Conclusion〛
100a
Landmarks Critical Care
Dr. Sherif Badrawy

202. ❀ In mechanically ventilated patients,
dexmedetomidine improved coma-free
days and time within goal level of sedation
compared to lorazepam, but required
more open-label fentanyl and had a higher
incidence of bradycardia.
100b
Landmarks Critical Care
Dr. Sherif Badrawy

203. OSCAR ➜ Young 2013 ➜ High-
Frequency Oscillation for
ARDS〚Randomization〛
101a
Landmarks Critical Care
Dr. Sherif Badrawy

204. ❐ Randomized patients to high-
frequency oscillation ventilation
(HFOV- Nova lung R100) or
conventional low tidal volume
mechanical ventilation.
101b
Landmarks Critical Care
Dr. Sherif Badrawy

205. OSCAR ➜ Young 2013 ➜ High-
Frequency Oscillation for
ARDS〚Conclusion〛
102a
Landmarks Critical Care
Dr. Sherif Badrawy

206. ❀ High-frequency oscillation
ventilation in patients with ARDS
did not improve mortality or length
of stay compared to conventional,
low tidal volume mechanical
ventilation.
102b
Landmarks Critical Care
Dr. Sherif Badrawy

207. OSCILLATE ➜ Ferguson 2013 ➜
High-frequency oscillation for
ARDS〚Randomization〛
103a
Landmarks Critical Care
Dr. Sherif Badrawy

208. ❐ Randomized patients to high-frequency
oscillation ventilation (HFOV Sensor
Medics 3100 B) or conventional low tidal
volume mechanical ventilation.
❐ Both groups had specific, protocolized
titration and weaning procedures.
103b
Landmarks Critical Care
Dr. Sherif Badrawy

209. OSCILLATE ➜ Ferguson 2013 ➜
High-frequency oscillation for
ARDS〚Conclusion〛
104a
Landmarks Critical Care
Dr. Sherif Badrawy

210. ❀ High-frequency oscillation
ventilation in patients with early
ARDS increased mortality compared
to conventional, low tidal volume
mechanical ventilation.
104b
Landmarks Critical Care
Dr. Sherif Badrawy

211. PRODEX ➜ Jakob 2012 ➜
Dexmedetomidine vs.
propofol〚Randomization〛
105a
Landmarks Critical Care
Dr. Sherif Badrawy

212. ❐ Randomized patients to receive
propofol (5-66 mcg/kg /min) vs.
dexmedetomidine (0.2-1.4
mcg/kg/hr) for up to 14 days.
Loading doses were not allowed
105b
Landmarks Critical Care
Dr. Sherif Badrawy

213. PRODEX ➜ Jakob 2012 ➜
Dexmedetomidine vs.
propofol〚Conclusion〛
106a
Landmarks Critical Care
Dr. Sherif Badrawy

214. ❀ In mechanically ventilated patients,
propofol was comparable to
dexmedetomidine with respect to time
within goal sedation, duration of
mechanical ventilation, and ICU length of
stay.
106b
Landmarks Critical Care
Dr. Sherif Badrawy

215. SEDCOM ➜ Riker 2009 ➜
Dexmedetomidine vs
midazolam〚Randomization〛
107a
Landmarks Critical Care
Dr. Sherif Badrawy

216. ❐ Randomized to dexmedetomidine
0.8 mcg/kg/hr (titrated 0.2-1 .4
mcg/kg/hr) or midazolam 0.06
mg/kg/hr (titrated 0.02- 0.1
mg/kg/hr) for up to 30 days
107b
Landmarks Critical Care
Dr. Sherif Badrawy

217. SEDCOM ➜ Riker 2009 ➜
Dexmedetomidine vs
midazolam〚Conclusion〛
108a
Landmarks Critical Care
Dr. Sherif Badrawy

218. ❀ In mechanically ventilated
patients, dexmedetomidine was
equivalent to midazolam in
achieving sedation goals, but
reduced ICU delirium and duration
of mechanical ventilation.
108b
Landmarks Critical Care
Dr. Sherif Badrawy

219. SLEAP ➜ Mehta 2012 ➜ Light
sedation with and
without daily
interruption〚Randomization〛
109a
Landmarks Critical Care
Dr. Sherif Badrawy

220. ❐ Randomized patients to
protocolized sedation plus daily
interruption ("interruption" group)
or protocolized sedation alone
("control")
109b
Landmarks Critical Care
Dr. Sherif Badrawy

221. SLEAP ➜ Mehta 2012 ➜ Light
sedation with and
without daily
interruption〚Conclusion〛
110a
Landmarks Critical Care
Dr. Sherif Badrawy

222. ❀ In mechanically ventilated patients with
a light sedation strategy, daily interruption
of sedation did not improve patient
outcomes. In fact, interruption was
associated with higher opioid and
benzodiazepine requirements.
110b
Landmarks Critical Care
Dr. Sherif Badrawy

223. STROM 2010 ➜ Sedationless
mechanical ventilation
〚Randomization〛
111a
Landmarks Critical Care
Dr. Sherif Badrawy

224. ❐ Randomized patients to
intervention ("no sedation") or
control (sedation with daily
interruption)
111b
Landmarks Critical Care
Dr. Sherif Badrawy

225. STROM 2010 ➜ Sedationless
mechanical ventilation
〚Conclusion〛
112a
Landmarks Critical Care
Dr. Sherif Badrawy

226. ❀ A protocol for little or no sedation
among mechanically ventilated patients
reduced the duration of mechanical
ventilation and ICU length of stay,
although it may increase the incidence of
delirium.
112b
Landmarks Critical Care
Dr. Sherif Badrawy

227. Bellomo 2001 ➜ ANZICS Dopamine
Renally-dosing dopamine in early
renal
dysfunction〚Randomization〛
113a
Landmarks Critical Care
Dr. Sherif Badrawy

228. ❐ Randomized patients to receive
dopamine 2 meg/kg/min or placebo
until renal replacement therapy,
death, discharge from ICU, or renal
dysfunction and SIRS resolved for>
24 hrs
113b
Landmarks Critical Care
Dr. Sherif Badrawy

229. Bellomo 2001 ➜ ANZICS Dopamine
Renally-dosing dopamine in early
renal dysfunction〚Conclusion〛
114a
Landmarks Critical Care
Dr. Sherif Badrawy

230. ❀ The use of "renal dose" dopamine
did not reduce peak creatinine, the
need for renal replacement therapy,
ICU length of stay, or mortality.
114b
Landmarks Critical Care
Dr. Sherif Badrawy

231. RENAL ➜ RENAL Replacement
Therapy Study Investigators 2009 ➜
Higher vs. lower-intensity
continuous renal replacement
therapy
〚Randomization〛
115a
Landmarks Critical Care
Dr. Sherif Badrawy

232. ❐ Randomized patients to receive
continuous venovenous
hemodiafiltration (CVVHDF) with
an effluent rate of 40 ml/kg/hr
("higherintensity") or 25 ml/kg/hr
("lower intensity")
115b
Landmarks Critical Care
Dr. Sherif Badrawy

233. RENAL ➜ RENAL Replacement
Therapy Study Investigators 2009 ➜
Higher vs. lower-intensity
continuous renal replacement
therapy
〚Conclusion〛
116a
Landmarks Critical Care
Dr. Sherif Badrawy

234. ❀ In patients requiring CRRT, higher-
intensity CVVHDF (40 ml/kg/hr) did not
improve any clinical endpoints compared
to lower intensity (25 ml/k /hr) therapy
but was associated with a higher filter
replacement rate and hypophosphatemia.
116b
Landmarks Critical Care
Dr. Sherif Badrawy

235. Allen 1983 ➜ Nimodipine for
cerebral vasospasm
〚Randomization〛
117a
Landmarks Critical Care
Dr. Sherif Badrawy

236. ❐ Randomized patients to receive
nimodipine 0.7 mg/kg PO bolus,
then 0.35 mg/kg (28 mg for 80 kg
patient) PO Q4h vs. placebo x 21
days
117b
Landmarks Critical Care
Dr. Sherif Badrawy

237. Allen 1983 ➜ Nimodipine for
cerebral vasospasm
〚Conclusion〛
118a
Landmarks Critical Care
Dr. Sherif Badrawy

238. ❀ Among patients with aneurysmal
SAH, nimodipine reduced
neurologic deficit and mortality
secondary to vasospasm.
118b
Landmarks Critical Care
Dr. Sherif Badrawy

239. Bracken 1984 ➜
Methylprednisolone for acute spinal
cord injury〚Randomization〛
119a
Landmarks Critical Care
Dr. Sherif Badrawy

240. ❐ Randomized patients to low or high dose
methylprednisolone x 1 0 days. Low dose was 1
00 mg IV loading dose, then 25 mg IV Q 6h. High
dose was 1 0 times the dose (1 000 mg load, 250
mg IV Q 6h)
❐ Excluded nerve root or cauda equina only and
gunshot wounds
119b
Landmarks Critical Care
Dr. Sherif Badrawy

241. BrackenI ➜ Bracken 1984 ➜
Methylprednisolone for acute spinal
cord injury〚Conclusion〛
120a
Landmarks Critical Care
Dr. Sherif Badrawy

242. ❀ High dose methylprednisolone did not
improve neurologic outcomes compared to
low dose methylprednisolone in patients
with spinal cord injury presenting within
48 hours. High dose was associated with
more wound infections.
120b
Landmarks Critical Care
Dr. Sherif Badrawy

243. BrackenII➜ Bracken 1990 ➜
Methylprednisolone, naloxone for
acute spinal cord
injury〚Randomization〛
121a
Landmarks Critical Care
Dr. Sherif Badrawy

244. ❐ Randomized patients to
methylprednisolone 30 mg/kg bolus
(over 15 min, then 45 min pause),
then 5.4 mg/kg/hr x 23 hrs,
naloxone infusion or placebo
121b
Landmarks Critical Care
Dr. Sherif Badrawy

245. BrackenII➜ Bracken 1990 ➜
Methylprednisolone, naloxone for
acute spinal cord
injury〚Conclusion〛
122a
Landmarks Critical Care
Dr. Sherif Badrawy

246. ❀ In patients with spinal cord injury,
methylprednisolone improved motor and
sensory function if initiated within 8 hours
of initial trauma. Patients receiving
methylprednisolone may be at higher risk
for wound infections and Gl bleeding.
122b
Landmarks Critical Care
Dr. Sherif Badrawy

247. BrackenIII➜ Bracken 1997 ➜
Methylprednisolone, tirilazad for
acute spinal cord
injury〚Randomization〛
123a
Landmarks Critical Care
Dr. Sherif Badrawy

248. ❐ Randomized patients to 24-hour
methylprednisolone, 48-hour
methylprednisolone, or tirilizad (lipid peroxidase
inhibitor). All patients received 20-40 mg/kg
methylprednisolone bolus
❐ Excluded patients> 109 kg (concern for fluid
overload), gunshot wounds
123b
Landmarks Critical Care
Dr. Sherif Badrawy

249. BrackenIII➜ Bracken 1997 ➜
Methylprednisolone, tirilazad for
acute spinal cord
injury〚Conclusion〛
124a
Landmarks Critical Care
Dr. Sherif Badrawy

250. ❀ In patients with acute spinal cord injury presenting
within 3 hours of injury, 24- hours of
methylprednisolone was equivalent to a 48-hour
infusion. For those presenting 3-8 hours post-injury,
48-hours of methylprednisolone improved motor
function and quality of life measures compared to a
24-hour infusion. Patients with 48-hour infusions
were more likely to develop pneumonia or severe
sepsis.
124b
Landmarks Critical Care
Dr. Sherif Badrawy

251. CAST ➜ CAST Investigators 1997 ➜
Early aspirin use in acute ischemic
stroke〚Randomization〛
125a
Landmarks Critical Care
Dr. Sherif Badrawy

252. ❐ Randomized to aspirin 1 60 mg
PO daily or placebo x 28 days
125b
Landmarks Critical Care
Dr. Sherif Badrawy

253. CAST ➜ CAST Investigators 1997 ➜
Early aspirin use in acute ischemic
stroke〚Conclusion〛
126a
Landmarks Critical Care
Dr. Sherif Badrawy

254. ❀ In patients with acute ischemic
stroke, aspirin within 48 hours
reduced 28-day mortality and
recurrent ischemic stroke, although
bleeding events were rare but
slightly more common with aspirin.
126b
Landmarks Critical Care
Dr. Sherif Badrawy

255. CATIS ➜ He 2014 ➜ BP reduction
in ischemic stroke
〚Randomization〛
127a
Landmarks Critical Care
Dr. Sherif Badrawy

256. ❐ Randomized patients to antihypertensive
treatment ("treatment") or usual care
("control"). Participants were encouraged to
remain hospitalized for 10 days.
❐ Excluded patients who received thrombolytic
therapy (TPA), diastolic BP > 120 mmHg, atrial
fibrillation, and unstable angina
127b
Landmarks Critical Care
Dr. Sherif Badrawy

257. CATIS ➜ He 2014 ➜ BP reduction
in ischemic stroke
〚Conclusion〛
128a
Landmarks Critical Care
Dr. Sherif Badrawy

258. ❀ Among patients with ischemic
stroke who do not receive TPA,
more aggressive blood pressure
reduction during hospitalization
does not improve mortality or major
disability.
128b
Landmarks Critical Care
Dr. Sherif Badrawy

259. DECRA ➜ Cooper 2011 ➜
Decompressive craniectomy in
traumatic brain injury
〚Randomization〛
129a
Landmarks Critical Care
Dr. Sherif Badrawy

260. ❐ Randomized to bifrontotemporoparietal
decompressive craniectomy (without division of
sagittal sinus and falx cerebri) plus standard of
care or standard of care alone
❐ Excluded patients with dilated, unreactive
pupils and mass lesions that would normally
require surgical intervention
129b
Landmarks Critical Care
Dr. Sherif Badrawy

261. DECRA ➜ Cooper 2011 ➜
Decompressive craniectomy in
traumatic brain injury
〚Conclusion〛
130a
Landmarks Critical Care
Dr. Sherif Badrawy

262. ❀ Bifrontotemporoparietal decompressive
craniectomy reduces ICP in patients with
severe traumatic brain injury without mass
lesions, but does not improve (and may
worsen) functional or unfavorable
outcomes.
130b
Landmarks Critical Care
Dr. Sherif Badrawy

263. ECASS III ➜ Hacke 2008 ➜
Alteplase 3 to 4.5 hours after acute
ischemic stroke
〚Randomization〛
131a
Landmarks Critical Care
Dr. Sherif Badrawy

264. ❐ Included 821 patients presenting
between 3 and 4.5 hours of ischemic
stroke not meeting a long list of
exclusion criteria, many related to
risk of bleeding.
131b
Landmarks Critical Care
Dr. Sherif Badrawy

265. ECASS III ➜ Hacke 2008 ➜
Alteplase 3 to 4.5 hours after acute
ischemic stroke
〚Conclusion〛
132a
Landmarks Critical Care
Dr. Sherif Badrawy

266. ❀ In patients presenting 3 to 4.5 hours of
ischemic stroke (beyond the NINDS 3 hour
window), alteplase improved 3-month
favorable outcome (NNT 14) but increased
the rate of symptomatic ICH (NNH 48).
There were pertinent new exclusion
criteria that were not present in NINDS.
132b
Landmarks Critical Care
Dr. Sherif Badrawy

267. FAST ➜ Mayer 2008 ➜ rFVIIa for
acute ICH
〚Randomization〛
133a
Landmarks Critical Care
Dr. Sherif Badrawy

268. ❐ Randomized to receive 20 or 80 mcg/kg
recombinant activated factor VII (rFVIIa) or placebo.
Treatment was given within 4 hours of symptom
onset
❐ Excluded deep coma (Glasgow <= 5), aneurysm, AV
malformation, trauma, known coagulopathy, and a
history of thromboembolic disease
133b
Landmarks Critical Care
Dr. Sherif Badrawy

269. FAST ➜ Mayer 2008 ➜ rFVIIa for
acute ICH
〚Conclusion〛
134a
Landmarks Critical Care
Dr. Sherif Badrawy

270. ❀ Recombinant activated factor VII
reduced hematoma growth at 24 hours,
but did not have a clinical benefit (death
or disability at 90 days). Arterial
thromboembolic events were more
common with rFVIIa.
134b
Landmarks Critical Care
Dr. Sherif Badrawy

271. GOLD2007 ➜ Adjunct
phenobarbital for
delirium tremens
〚Randomization〛
135a
Landmarks Critical Care
Dr. Sherif Badrawy

272. ❐ 95 patients admitted to a
medicaiiCU for severe alcohol
withdrawal requiring at least 200
mg diazepam in 4 hours or a single
dose of 40 mg diazepam
135b
Landmarks Critical Care
Dr. Sherif Badrawy

273. GOLD 2007 ➜ Adjunct
phenobarbital for
delirium tremens
〚Conclusion〛
136a
Landmarks Critical Care
Dr. Sherif Badrawy

274. ❀ A protocol emphasizing escalating
diazepam doses and adjunct phenobarbital
in severe alcohol withdrawal reduced the
need for mechanical ventilation compared
to no treatment protocol.
136b
Landmarks Critical Care
Dr. Sherif Badrawy

275. NINDS 1995 ➜ Alteplase within 3
hours for acute ischemic stroke
〚Randomization〛
137a
Landmarks Critical Care
Dr. Sherif Badrawy

276. ❐ Included 624 patients presenting within
3 hours of ischemic stroke not meeting a
long list of exclusion criteria, many related
to risk of bleeding. There was no
exclusion on the basis of severity of stroke
or maximum age.
137b
Landmarks Critical Care
Dr. Sherif Badrawy

277. NINDS 1995 ➜ Alteplase within 3
hours for acute ischemic stroke
〚Conclusion〛
138a
Landmarks Critical Care
Dr. Sherif Badrawy

278. ❀ In patients presenting within 3 hours of
ischemic stroke, alteplase improved 3- month
neurological function (NNT=9) but did not
impact 24-hour symptoms or mortality. In
patients receiving alteplase, approximately one-
quarter had minor bleeding, and 6.4% had
symptomatic ICH (NNH=17).
138b
Landmarks Critical Care
Dr. Sherif Badrawy

279. Pickard 1989 ➜ British aneurysm
nimodipine trial
〚Randomization〛
139a
Landmarks Critical Care
Dr. Sherif Badrawy

280. ❐ patients with aneurysmal (non-
traumatic) subarachnoid
hemorrhage within 96 hour.
Randomized patients to nimodipine
60 mg PO Q4h or placebo x 21 days
139b
Landmarks Critical Care
Dr. Sherif Badrawy

281. Pickard 1989 ➜ British aneurysm
nimodipine trial
〚Conclusion〛
140a
Landmarks Critical Care
Dr. Sherif Badrawy

282. ❀ Nimodipine reduced cerebral
infarction and 3-month functional
outcomes in patients with
aneurysmal subarachnoid
hemorrhage.
140b
Landmarks Critical Care
Dr. Sherif Badrawy

283. Temkin1990 ➜ Phenytoin for post-
traumatic seizure prophylaxis
〚Randomization〛
141a
Landmarks Critical Care
Dr. Sherif Badrawy

284. ❐ Randomized patients to receive
phenytoin (20 mg/kg load then
daily doses adjusted based on levels)
or placebo x 12 months. Goal
phenytoin levels were 10-20 mcg/ml
(total) and 0.75-1.5 mcg/ml (free)
141b
Landmarks Critical Care
Dr. Sherif Badrawy

285. Temkin1990 ➜ Phenytoin for post-
traumatic seizure prophylaxis
〚Conclusion〛
142a
Landmarks Critical Care
Dr. Sherif Badrawy

286. ❀ In patients with severe head
injury, phenytoin reduced seizures
within the first 7 days, but had no
effect in preventing late onset
seizures.
142b
Landmarks Critical Care
Dr. Sherif Badrawy

287. Temkin1999 ➜ Valproate for post-
traumatic seizure prophylaxis
〚Randomization〛
143a
Landmarks Critical Care
Dr. Sherif Badrawy

288. ❐ Randomized patients to receive
phenytoin for 1 week, valproate for 1
month, or valproate for 6 months
143b
Landmarks Critical Care
Dr. Sherif Badrawy

289. Temkin 1999 ➜ Valproate for post-
traumatic seizure prophylaxis
〚Conclusion〛
144a
Landmarks Critical Care
Dr. Sherif Badrawy

290. ❀ In patients with severe head
injury, valproate does not provide
any benefit over phenytoin in
reducing early or late seizures and
may increase 2-year mortality.
144b
Landmarks Critical Care
Dr. Sherif Badrawy

291. Treiman 1998 ➜ Comparison of four
treatments for status epilepticus
〚Randomization〛
145a
Landmarks Critical Care
Dr. Sherif Badrawy

292. ❐ Randomized to receive lorazepam
(0.1 mg/kg), phenobarbital (15
mg/kg), phenytoin (18 mg/kg), or
diazepam (0.15 mg/kg) with
phenytoin (18 mg/kg)
145b
Landmarks Critical Care
Dr. Sherif Badrawy

293. Treiman 1998 ➜ Comparison of four
treatments for status epilepticus
〚Conclusion〛
146a
Landmarks Critical Care
Dr. Sherif Badrawy

294. ❀ In patients with overt status epilepticus,
lorazepam was superior to phenytoin but
equivalent to phenobarbital or phenytoin/
diazepam. No agent showed superior
efficacy for subtle status, which had much
worse outcomes compared to overt status.
146b
Landmarks Critical Care
Dr. Sherif Badrawy

295. Devlin 2010 ➜ Quetiapine for ICU
delirium
〚Randomization〛
147a
Landmarks Critical Care
Dr. Sherif Badrawy

296. ❐ Randomized patients to quetiapine or placebo
until delirium has resolved, 10 days had elapsed,
or ICU discharge
❐ Excluded 86% of screened patients (222/ 258)
limiting external validity and potentially
underpowering any secondary efficacy or safety
analyses
147b
Landmarks Critical Care
Dr. Sherif Badrawy

297. Devlin 2010 ➜ Quetiapine for ICU
delirium
〚Conclusion〛
148a
Landmarks Critical Care
Dr. Sherif Badrawy

298. ❀ Quetiapine may result in a faster
resolution of delirium and prevent
additional episodes of delirium,
although this effect does not translate
to a shorter length of stay or
mortality benefit.
148b
Landmarks Critical Care
Dr. Sherif Badrawy

299. ACURASYS ➜ Papazian 2010 ➜
Cisatracurium for early ARDS
〚Randomization〛
149a
Landmarks Critical Care
Dr. Sherif Badrawy

300. ❐ Randomized to placebo vs.
cisatracurium (15 mg bolus+ 37.5
mg/hr x 48 hrs)
149b
Landmarks Critical Care
Dr. Sherif Badrawy

301. ACURASYS ➜ Papazian 2010 ➜
Cisatracurium for early ARDS
〚Conclusion〛
150a
Landmarks Critical Care
Dr. Sherif Badrawy

302. ❀ In patients with severe ARDS,
cisatracurium for 48 hours
decreased 90- day mortality,
although the analysis was limited by
unbalanced baseline characteristics.
150b
Landmarks Critical Care
Dr. Sherif Badrawy

303. ARDS Net 2000 ➜ Lower tidal
volumes for ARDS
〚Randomization〛
151a
Landmarks Critical Care
Dr. Sherif Badrawy

304. ❐ Randomized traditional tidal
volume (12 ml/kg ideal weight) or
lower tidal volume (6 ml/kg ideal
weight)
151b
Landmarks Critical Care
Dr. Sherif Badrawy

305. ARDS Net 2000 ➜ Lower tidal
volumes for ARDS
〚Conclusion〛
152a
Landmarks Critical Care
Dr. Sherif Badrawy

306. ❀ In patients with All/ ARDS, lower
tidal volume mechanical ventilation
improved mortality compared to
traditional tidal volumes.
152b
Landmarks Critical Care
Dr. Sherif Badrawy

307. Bouchard 2005 ➜ Noninvasive
ventilation for
acute COPD exacerbation
〚Randomization〛
153a
Landmarks Critical Care
Dr. Sherif Badrawy

308. ❐ Randomized patients to standard therapy
(oxygen up to 5 L/min with bronchodilators) or
standard therapy with period of noninvasive
ventilation (NIV) via facemask for at least 6 hours
per day
❐ Patients requiring immediate intubation were
excluded.
153b
Landmarks Critical Care
Dr. Sherif Badrawy

309. Bouchard 2005 ➜ Noninvasive
ventilation for
acute COPD exacerbation
〚Conclusion〛
154a
Landmarks Critical Care
Dr. Sherif Badrawy

310. ❀ Among a selected group of patients
with acute COPD exacerbation who
do not require immediate intubation,
noninvasive ventilation reduced the
need for endotracheal intubation,
length of stay, and mortality.
154b
Landmarks Critical Care
Dr. Sherif Badrawy

311. CESAR ➜ Peek 2009 ➜
Conventional vent support vs.
ECMO for ARDS
〚Randomization〛
155a
Landmarks Critical Care
Dr. Sherif Badrawy

312. ❐ Randomized to conventional ventilator
management or referral to Glenfield Hospital
with the intent to initiate ECMO (extracorporeal
membrane oxygenation)
❐ Excluded those with peak inspiratory pressure
> 30 or Fi02 > 80% for more than 7 days or
those with contra indications to anticoagulation
155b
Landmarks Critical Care
Dr. Sherif Badrawy

313. CESAR ➜ Peek 2009 ➜
Conventional vent support vs.
ECMO for ARDS
〚Conclusion〛
156a
Landmarks Critical Care
Dr. Sherif Badrawy

314. ❀ In patients with early ARDS,
transfer to a facility specializing in
ARDS with the ability to initiate
ECMO was associated with an
improvement in 6-month survival
without severe disability.
156b
Landmarks Critical Care
Dr. Sherif Badrawy

315. Esteban 2004 ➜ Noninvasive
ventilation after
extubation failure
〚Randomization〛
157a
Landmarks Critical Care
Dr. Sherif Badrawy

316. ❐ Randomized patients to medical
therapy (supplemental oxygen,
respiratory physiotherapy,
bronchodilators) or noninvasive
positive pressure ventilation with a
full facial mask
157b
Landmarks Critical Care
Dr. Sherif Badrawy

317. Esteban 2004 ➜ Noninvasive
ventilation after
extubation failure
〚Conclusion〛
158a
Landmarks Critical Care
Dr. Sherif Badrawy

318. ❀ In patients with the onset of respiratory
failure after extubation, noninvasive
positive-pressure ventilation was
associated with increased mortality, likely
due to delayed reintubation, compared to
conventional medical therapy.
158b
Landmarks Critical Care
Dr. Sherif Badrawy

319. FACCT ➜ ARDS Net 2006 ➜
Conservative vs. liberal fluid
management in ARDS
〚Randomization〛
159a
Landmarks Critical Care
Dr. Sherif Badrawy

320. ❐ Randomized conservative (net
even balance) vs. liberal (fluid-
positive) fluid management
strategies according to a strict
treatment protocol
159b
Landmarks Critical Care
Dr. Sherif Badrawy

321. FACCT ➜ ARDS Net 2006 ➜
Conservative vs. liberal fluid
management in ARDS
〚Conclusion〛
160a
Landmarks Critical Care
Dr. Sherif Badrawy

322. ❀ Compared to liberal fluid
management in All/ ARDS,
conservative strategies did not
improve 60-day mortality, but did
improve ventilator-free days and
ICU length of stay.
160b
Landmarks Critical Care
Dr. Sherif Badrawy

323. Meduri 1998 ➜ Meduri protocol for
unresolving ARDS
〚Randomization〛
161a
Landmarks Critical Care
Dr. Sherif Badrawy

324. ❐ Included 24 patients with ARDS who did not have improving lung
injury scores after 7 days, randomized 2:1 to methylprednisolone or
placebo
❐ Meduri 1998 methylprednisolone protocol (unresolving ARDS):
Doses given as IV infusions and divided into Q 6h. Once able to take
PO, doses given as single oral doses. Protocol: 2 mg/kg loading dose,
then 2 mg/kg/day (days 0- 14), then 1 mg/kg/day (days 15-21), then
0.5 mg/kg/day (days 22-28), then 0.25 mg/kg/day (days 29-30),
then 0.125 mg/ kg/day (days 31-32). If extubated prior to day 14,
treatment was advanced to day 15 of therapy.
161b
Landmarks Critical Care
Dr. Sherif Badrawy

325. Meduri 1998 ➜ Meduri protocol for
unresolving ARDS
〚Conclusion〛
162a
Landmarks Critical Care
Dr. Sherif Badrawy

326. ❀ Prolonged, low-dose
methylprednisolone in unresolving ARDS
improved ICU survival and lung function;
however, some experts believe that larger
studies are necessary in order to
characterize the efficacy and safety of this
regimen in unresolving ARDS.
162b
Landmarks Critical Care
Dr. Sherif Badrawy

327. Meduri 2007 ➜ Meduri protocol for
early ARDS
〚Randomization〛
163a
Landmarks Critical Care
Dr. Sherif Badrawy

328. ❐ Included 91 patients with ARDS onset within 72 hours,
randomized to methylprednisolone or placebo
❐ Meduri 2007 methylprednisolone protocol (early ARDS).
Doses given as IV infusions once daily. Once able to take PO,
doses were given as single oral doses. Protocol: 1 mg/kg
loading dose, then 1 mg/kg/day (days 0-14), then 0.5
mg/kg/day (days 15-21 ), then 0.25 mg/ kg/day (days 22-25),
then 0.125 mg/kg/ day (days 26-28). If extubated prior to
day 14, treatment was advanced to day 15 of therapy
163b
Landmarks Critical Care
Dr. Sherif Badrawy

329. Meduri 2007 ➜ Meduri protocol for
early ARDS
〚Conclusion〛
164a
Landmarks Critical Care
Dr. Sherif Badrawy

330. ❀ Prolonged, low-dose
methylprednisolone in early ARDS
improved lung function, duration of
mechanical ventilation, ICU length
of stay, and ICU survival.
164b
Landmarks Critical Care
Dr. Sherif Badrawy

331. PROSEVA ➜ Guerin 2013 ➜ Prone
positioning in severe
ARDS
〚Randomization〛
165a
Landmarks Critical Care
Dr. Sherif Badrawy

332. ❐ Included 466 patients with early (within 36 hours of
ARDS criteria), severe (Pa02:Fi02 < 150 mmHg) ARDS
❐ After a 12-24 hour stabilization period to verify inclusion
criteria, randomized patients to supine positioning (control)
or prone positioning (treatment) for up to 28 days. Many
other factors in ARDS management (mechanical ventilator
adjustments, weaning, sedation, and paralytics) were
protocolized
165b
Landmarks Critical Care
Dr. Sherif Badrawy

333. PROSEVA ➜ Guerin 2013 ➜ Prone
positioning in severe
ARDS
〚Conclusion〛
166a
Landmarks Critical Care
Dr. Sherif Badrawy

334. ❀ In patients with early, severe
ARDS, prone positioning for at least
16 hours per day significantly
reduced mortality.
166b
Landmarks Critical Care
Dr. Sherif Badrawy

335. Yang 1991 ➜ Rapid shallow
breathing index
to predict weaning failure
〚Randomization〛
167a
Landmarks Critical Care
Dr. Sherif Badrawy

336. ❐ Physicians were blinded to study
design the decision to extubate was
made solely based on the physician's
clinical
judgment
167b
Landmarks Critical Care
Dr. Sherif Badrawy

337. Yang 1991 ➜ Rapid shallow
breathing index
to predict weaning failure
〚Conclusion〛
168a
Landmarks Critical Care
Dr. Sherif Badrawy

338. ❀ In mechanically ventilated medical
ICU patients, a rapid shallow breathing
index (RSBI or f/Vt) cut-off of 100
breaths/min/L was the most sensitive
and specific
objective measure of extubation success.
168b
Landmarks Critical Care
Dr. Sherif Badrawy

339. Niewoehner 1999 ➜ Steroids for
COPD exacerbations
〚Randomization〛
169a
Landmarks Critical Care
Dr. Sherif Badrawy

340. ❐ Randomized patients within 1 2 hours of
presentation to long-term steroids (8
weeks), short-term steroids (2 weeks), or
placebo
Excluded those with asthma or
corticosteroid use in past 30 days
169b
Landmarks Critical Care
Dr. Sherif Badrawy

341. Niewoehner 1999 ➜ Steroids for
COPD exacerbations
〚Conclusion〛
170a
Landmarks Critical Care
Dr. Sherif Badrawy

342. ❀ In patients with COPD exacerbations,
corticosteroids decreased treatment failure and
hospital length of stay but increased
hyperglycemia and showed a trend towards more
non-COPD hospitalizations. There was no
difference between a 2-week and 8-week
corticosteroid regimen.
170b
Landmarks Critical Care
Dr. Sherif Badrawy

343. TracMan ➜ Young 2013 ➜ Early vs.
late tracheostomy
〚Randomization〛
171a
Landmarks Critical Care
Dr. Sherif Badrawy

344. ❐ Randomized patients to receive
early (within 4 days of ICU
admission) or late (day 10 or later)
tracheostomy
171b
Landmarks Critical Care
Dr. Sherif Badrawy

345. TracMan ➜ Young 2013 ➜ Early vs.
late tracheostomy
〚Conclusion〛
172a
Landmarks Critical Care
Dr. Sherif Badrawy

346. ❀ In patients likely to require at least 7
days of mechanical ventilation, early
tracheostomy did not improve mortality
but was associated with a higher rate of
unnecessary tracheostomy compared to
late tracheostomy.
172b
Landmarks Critical Care
Dr. Sherif Badrawy

347. CRASH-2 Collaborators 2010 ➜
Tranexamic acid in trauma patients
〚Randomization〛
173a
Landmarks Critical Care
Dr. Sherif Badrawy

348. ❐ Randomized to receive
tranexamic acid (1 gm loading dose
over 1 0 minutes, then 1 gm infusion
over 8 hrs) or placebo
173b
Landmarks Critical Care
Dr. Sherif Badrawy

349. CRASH-2 Collaborators 2010 ➜
Tranexamic acid in trauma patients
〚Conclusion〛
174a
Landmarks Critical Care
Dr. Sherif Badrawy

350. ❀ Tranexamic acid reduced all-
cause mortality in a broad
population of trauma patients
without an increase in vascular
occlusion complications.
174b
Landmarks Critical Care
Dr. Sherif Badrawy

351. CALORIES ➜ Harvey 2014 ➜ Early
enteral vs. parenteral nutrition
〚Randomization〛
175a
Landmarks Critical Care
Dr. Sherif Badrawy

352. ❐ Randomized patients to either 25
kcal/kg of parenteral or enteral
nutrition for 5 total days (or until
transition to exclusive oral feeding or
ICU discharge)
175b
Landmarks Critical Care
Dr. Sherif Badrawy

353. CALORIES ➜ Harvey 2014 ➜ Early
enteral vs. parenteral nutrition
〚Conclusion〛
176a
Landmarks Critical Care
Dr. Sherif Badrawy

354. ❀ Among a heterogeneous ICU
patient population, there was no
difference in mortality between
exclusive enteral and parenteral
nutrition support.
176b
Landmarks Critical Care
Dr. Sherif Badrawy

355. TRISS ➜ Holst 2014 ➜ Low vs. high
blood transfusion threshold in septic
shock
〚Randomization〛
177a
Landmarks Critical Care
Dr. Sherif Badrawy

356. ❐ Randomized patients to a low (7
g/ dL) or high (9 g/ dL) transfusion
threshold for the duration of the ICU
stay. All transfusions were single
unit with leukoreduced red cells.
177b
Landmarks Critical Care
Dr. Sherif Badrawy

357. TRISS ➜ Holst 2014 ➜ Low vs. high
blood transfusion threshold in septic
shock
〚Conclusion〛
178a
Landmarks Critical Care
Dr. Sherif Badrawy

358. ❀ In patients with septic shock, there was
no difference in mortality with a lower (7
g/ dL) transfusion threshold compared to
a higher (9 g/ dL) threshold. A lower
threshold was associated with less use of
blood transfusions.
178b
Landmarks Critical Care
Dr. Sherif Badrawy

359. ARISE 2014 ➜ Early goal-directed
therapy versus usual care in early
septic shock
〚Randomization〛
179a
Landmarks Critical Care
Dr. Sherif Badrawy

360. ❐ Randomized patients to a low (7 g/dL) or
high (9 g/dl) transfusion threshold for the
duration of the ICU stay. All transfusions
were single unit with leukoreduced red cells.
❐ Excluded patients with active bleeding or
acute coronary syndromes
179b
Landmarks Critical Care
Dr. Sherif Badrawy

361. ARISE 2014 ➜ Early goal-directed
therapy versus usual care in early
septic shock
〚Conclusion〛
180a
Landmarks Critical Care
Dr. Sherif Badrawy

362. ❀ Among patients with early septic shock
in the emergency department, there was
no difference in mortality between usual
care(without SCv02) and early goal-
directed therapy (based on the Rivers
2001 protocol).
180b
Landmarks Critical Care
Dr. Sherif Badrawy

363. Landmarks Critical Care
Dr. Sherif Badrawy