Evidence basedcritcare06
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  • 1. Evidence-based critical care – Update 2006 Joel Peerless MD 3 January 2006
  • 2. Intensivist shortage
    • Experts predict that as the US population ages, the shortage of intensivists will become increasingly acute
    • By 2020, the supply of intensivists will meet only 22% of the demand for their services
  • 3. The old way…
    • Intern/junior resident (Dr. X) was taught
    • a concept by his/her:
    • Senior resident
    • Chief resident
    • Fellow
    • Attending
    • Dr. X practiced what he was taught…
  • 4. The old way…
    • Dr. X went on to become:
    • A senior resident
    • A chief resident
    • A fellow
    • An attending
    • And taught the same concept to his/her junior resident, and so on and so on….
  • 5. The old way…”Why do you do it that way??”
    • “Well, I learned this from Dr. X”
    • “We’ve always done it this way”
    • “We have good outcomes”
    • “I have an article to prove it” (more on this later…)
  • 6. The old way… dopamine
    • Dopamine in low doses activates dopamine receptors in the kidney
    • Renal blood flow is increased
    • Urine output is increased (sometimes)
    • The assumption, and teaching, became…
  • 7. The old way… dopamine
    • Dopamine is indicated for:
    • Preventing renal failure
    • Treating renal failure
    • Reversing renal vasoconstriction when vasopressors are used
    • Preventing renal failure during aortic and renal cross-clamping
    • Dopamine flowed like water (often better than urine) in ICUs worldwide
  • 8. Evidence-based critical care
    • THERE NOW EXISTS A MORE “SCIENTIFIC” METHOD TO PROVIDE CARE…
  • 9. The new way…
    • Try to adapt practice based on the quality of clinical studies that support the test or intervention – “Evidence-based”
    • A careful evaluation of existing studies
      • Type of trial
      • Number of centers
      • Number of patients
      • Quality of the study
  • 10. Evidence-based concepts
    • The best study is:
    • Prospective
    • Randomized
    • Double Blinded – not always possible
    • Multicenter
    • Meta-analyses evaluate a number of similar studies
  • 11. Evidence-based concepts
    • Surviving Sepsis Campaign Guidelines for the Management of Severe Sepsis and Septic Shock
    • 11 critical care societies - international
    • Initial document: CCM March, 2004
    • Evidence-based review: CCM supplement November, 2004
  • 12. Grading system
    • Grade A: At least 2 large, randomized trials with clearcut results
    • Grade B: At least 1 large, randomized trial with clearcut results
    • Grade C: Small, randomized trials, uncertain results
  • 13. Grading system
    • Grade D: Nonrandomized, contemporaneous controls
    • Grade E: Nonrandomized, historical controls; case series; uncontrolled studies; expert opinion
  • 14. Evidence-based critical care
    • VENTILATOR MANAGEMENT OF ARDS
    • Vt settings
    • Level of PEEP
    • Use of steroids in “late” ARDS
  • 15. Low tidal volume strategy
    • Barotrauma
      • High pressure generated with flow of air into lungs
    • Volume trauma (volutrauma)
      • Overdistention of alveoli can lead to further lung damage
  • 16. Low tidal volume strategy
    • Classic practice: Vt 10-15 cc/kg
    • Hypothesis: lower Vt is protective of alveolar damage and outcome in ARDS
    • ARDS-net trial, NEJM, 2000
    • Comparison of 6 ml/kg vs 12 ml/kg
    • 861/1000 patients
    • Mortality 31% vs 39.8%
    • Reduction in mortality of 22%
  • 17. Low tidal volume strategy
    • When ARDS diagnosed, adjust Vt for ideal body weight
      • 60 kg x .6 cc/kg = 360 cc
    • pCO 2 will likely increase – permissive hypercapnea
    • GRADE B
  • 18. PEEP levels in ARDS
    • ARDS-net, NEJM, 2004
    • Comparison of low and high PEEP in ARDS
    • 549 patients
    • Low versus high PEEP algorithm
    • All patients had low Vt
    • No difference in ventilator free days or mortality
  • 19. Steroids for “late” ARDS
    • Fibroproliferation can occur after 5-7 days of ARDS
    • This inflammatory process may present with worsening oxygenation, fever and leukocytosis (infection may present with same signs)
    • Case series of steroids to minimize the late inflammatory fibroproliferation
  • 20. Steroids for “late” ARDS
    • ARDS-net randomized placebo-controlled trial
    • Goal 200 patients over 6-8 years
    • No value in use of steroids in “late” ARDS
  • 21. Other ARDS modalities
    • We no longer consider:
    • Prone position
    • Inhaled nitric oxide
    • Surfactant
    • Liquid ventilation
  • 22. Evidence-based critical care
    • Glucose control in critically ill patients
  • 23. Intensive insulin therapy
    • NEJM, 2001, single center study
    • 1,548 surgical patients
    • Randomized to tight vs non tight control
    • 80-120 mg/dl vs 150 mg/dl
    • ICU mortality 4.6% vs 8.0%
    • 43% risk reduction
  • 24. Intensive insulin therapy
    • 50% decrease in BSI, ARF requiring RRT, critical illness polyneuropathy and transfusion requirement
    • Shorter duration of mechanical ventilation and ICU care
    • Less multiple organ failure
  • 25. Intensive insulin therapy
    • Mayo Clin Proc, 2004
    • 800 critically ill medical-surgical patients in a community ICU
    • Hospital mortality decreased
    • Decreased ICU LOS, ARF, transfusion requirement
    • Most benefit in septic patients
  • 26. Intensive insulin therapy
    • GRADE D based on original study, (randomized but single center, mainly surgical patients), likely upgrade to C
    • German study (600 patients) – negative
    • Two large scale randomized trials underway
      • European study – 3500 medical/surgical patients
      • Australia/NZ – 4500 medical/surgical patients
  • 27. Evidence-based critical care
    • Activated protein-C in sepsis (Xigris)
  • 28.  
  • 29.  
  • 30. RH Activated Protein C
    • Prowess Study
      • Recombinant human activated pro tein C w orldwide e valuation in s evere s epsis
      • Randomized, double blinded, placebo controlled
      • 96 hour infusion of activated protein C (APC)
      • Endpoint: death at 28 days
  • 31. RH Activated Protein C
    • Prowess study
      • 1690 patients (840 placebo; 850 APC)
      • Mortality 30% vs 24.7%, p=0.005
      • 6.1% reduction of death
      • Serious bleeding 2% vs 3.5%, p=0.06
      • Similar number of blood transfusions
  • 32. RH Activated Protein C
    • Prowess study
      • The difference in outcome was greatest in patients with an APACHE score >25
    • Address study
      • PRCT of RHAPC in patients with APACHE <25
      • No improvement in outcome
      • May be worse outcome in SURGICAL patients with single organ dysfunction
  • 33. RH Activated Protein C
    • Contraindications
      • Internal bleeding, hemorrhagic CVA, CHI, neurosurgical procedures, surgery within 12 hours
      • Many patients with abdominal sepsis require repeat explorations
    • The drug is expensive ($100/kg)
  • 34. RH Activated Protein C
    • GRADE B for patients with severe sepsis, multiple organ dysfunction, with APACHE >25
    • “Dear doctor” letter from Eli Lilly re: surgical patients with single organ dysfunction
  • 35. Evidence-based critical care
    • CORTICOSTEROIDS AND SEPTIC SHOCK
  • 36. Corticosteroids and sepsis
    • Old teaching: don’t give septic patients high dose steroids
    • New thought: patients with septic shock who are unresponsive to pressor agents may have adrenal insufficiency
  • 37. Corticosteroids and sepsis
    • Incidence of adrenal insufficiency
      • 30-50% in critically ill patients
      • 50-60% in patients with septic shock
    • Clinical presentation
      • resistant hypotension
      • hyponatremia, hyperkalemia
    • Low or “normal” serum cortisol level
  • 38. Corticosteroids and sepsis
    • JAMA, 2002; multicenter, RCT, 300 patients
    • Septic shock, vasopressor therapy
    • A baseline cortisol level of <25 mcg/dl
    • Corticotropin stimulation test (cortrosyn)
    • An increase in serum cortisol of 9 mcg/dl after corticotropin – “responders”
    • Unable to increase serum cortisol 9 mcg/dl – “nonresponders”
  • 39. Corticosteroids and sepsis
    • Nonresponders randomized to placebo vs hydrocortisone 50 mg IV every 6 hours + fludrocortisone
    • Mortality improved in patients with adrenal insufficiency
    • Faster time to vasopressor withdrawal
    • No difference in patients with adequate corticotropin response
  • 40. Corticosteroids and sepsis
    • Should low doses of corticosteroids be used in the treatment of septic shock?
    • GRADE C
    • SSC guidelines suggest steroids in pressor-dependent patients with low serum cortisol (don’t even bother with the cortrosyn stimulation)
  • 41. Evidence-based critical care
    • PULMONARY ARTERY CATHETER USE IN THE ICU
  • 42. PA catheter use in the ICU
    • Old practice: any unstable patient who didn’t respond to fluids or who had possible cardiac dysfunction; “we didn’t know where we were…”
    • Preoperative “optimization” of high risk patients
    • Old practices questioned: Connors, et al, JAMA, 1996
    • Editorial: “abandon PACs until PRCT”
  • 43. PA catheter use in the ICU
    • JAMA, 2005
    • Meta-analysis, 13 RCTs, 5051 patients
    • Use of PA catheter neither increased overall mortality or hospital days, nor conferred benefit
    • Use of the PA catheter was associated with a higher use of inotropes and vasodilators
  • 44. PA catheter use in the ICU
    • RCT in progress
    • ARDS-net, 1000 patient goal
    • FACTT Study: PRMCT of PAC vs CVP for management of ALI and ARDS
    • and
    • PRMCT of “fluid conservative” vs “fluid liberal” management of ALI and ARDS
  • 45. Evidence-based critical care
    • EARLY GOAL-DIRECTED THERAPY IN SEPSIS
  • 46. Early goal-directed therapy
    • “Standard” goals for sepsis (resuscitation)
      • MAP > 65
      • CVP 8-12
      • Urine output >0.5 cc/hr
  • 47. Early goal-directed therapy
    • DO 2 = Hgb (SaO 2 ) x 1.34 x CI x 10
    • “ Supranormal” goals for PAC (1980s)
      • CI > 4.5 L/min/m 2
      • DO 2 I > 600 ml O 2 /min/m 2
      • VO 2 I > 170 ml 0 2 /min/m 2
    • Fluids, blood, inotropes, pressors…
    • We could measure our progress with a calculator!!
  • 48. Early goal-directed therapy
    • Supranormal goals disproven in established sepsis (NEJM x2)
    • Will this theory work if we get to the patient earlier?
  • 49. Early goal-directed therapy
    • NEJM, 2001, Henry Ford Hospital
    • 263 ED patients
    • Control group: MAP, CVP, UO
    • Protocol group: MAP, CVP, UO, SCVO 2 >70
    • Mortality 46.5 vs 30.5%, p=.009
  • 50. Early goal-directed therapy
    • There IS value to optimizing cardiac output, oxygen delivery and SVO 2 if you intervene early enough
    • (Is it really the SVO 2 that makes the difference, or is it resuscitation??)
  • 51. Evidence-based critical care
    • ANTIBIOTICS and INFECTION CONTROL
    • WHO NEEDS TREATMENT AND FOR HOW LONG
    • VENTILATOR ASSOCIATED PNEUMONIA
    • CATHETER-RELATED BACTERIAL STREAM INFECTION
    • C-DIFFICILE COLITIS
  • 52. Who needs antibiotics?
    • Systemic inflammatory response syndrome (SIRS)
    • Fever means inflammation , not necessarily infection
    • Emergence of multiresistant bacteria
    • Treating fever alone or fever + WBC without a source of infection is usually not in the best interest of the patient
  • 53. Duration of antibiotic coverage
    • Minimal data over duration of antibiotic usage for most infections
      • Bacteremia – 2 weeks
      • Endocarditis – 6 weeks
    • What about “double coverage” for pneumonia
      • SPACE bugs: S erratia, P seudomonas, A cinetobacter, C itrobacter, E nterobacter
      • VAP coverage was always 2 weeks
  • 54. SICU antibiotic usage
    • Perioperative coverage – single dose or 24 hours of coverage
    • UTI – 5 days
    • Sinusitis – 5-7 days
    • Bacteremia – 10 days
  • 55. Evidence-based critical care
    • VENTILATOR-ASSOCIATED PNEUMONIA
    • DIAGNOSIS
    • TREATMENT
    • PREVENTION
  • 56. Ventilator-associated pneumonia - diagnosis
    • Classic teaching: Fever, WBC, purulent sputum, + culture, infiltrate
    • 75% of intubated patients are colonized with GNB after 3 days in the ICU
    • You could have bronchitis or sinusitis + atelectasis, or pulmonary edema
    • Endotracheal aspirate vs BAL
      • BAL samples give quantitative cultures
  • 57. Ventilator-associated pneumonia - diagnosis
    • Fever/WBC, + culture without purulent sputum or CXR – NO ANTIBIOTICS
    • Fever/WBC, purulent sputum or changing CXR, + sputum culture -> empiric therapy
    • Fever/WBC, purulent sputum or changing CXR, + sputum culture -> BAL + empiric therapy
  • 58. Ventilator-associated pneumonia treatment
    • JAMA, 2003
    • PRCDBT, 51 French ICUs, 401 patients
    • VAP treatment for 8 vs 15 days
    • No excess mortality, recurrent infections, ventilator days, ICU LOS with 8 day treatment
    • But, recurrence of VAP was higher with PSD
  • 59. Ventilator-associated pneumonia prevention
    • Subglottic suctioning of secretions
      • Additional suction port above the ETT cuff
      • Some studies suggest decreased VAP
      • Who will get them, will you risk changing the tube??
    • Role of gastric contents
      • Gastric residuals: not shown to correlate with VAP (a major cause of poor nutrition)
  • 60. Ventilator-associated pneumonia
    • What is known
      • More likely from mouth contents than from regurgitation of stomach contents
      • Head of bed 30 degrees up is the only proven preventive technique!!
      • Early effective antibiotic therapy is essential !!
      • Start with broad-spectrum coverage, then taper antibiotics based on EA/BAL results
  • 61. Catheter-related BSI
    • Prevention – what doesn’t work
      • Changing lines every three days
      • Performing wire changes
      • Putting antibiotic solutions (goop) on the site
      • Antibiotic lock solutions
  • 62. Catheter-related BSI
    • Prevention – what DOES work
      • Subclavian site
      • Prep: Chlorhexidine (not povidone)
      • Barrier precautions: Hat, mask, gown, gloves, FULL body drape
      • Antiseptic coated catheters ($$$; beware of hospital administrators)
      • Management of stopcocks: alcohol prior to injections, keep ports closed
  • 63.  
  • 64. C-difficile colitis
    • Related to indiscriminate antibiotic usage
    • May occur with only a single dose of antibiotics (even perioperative coverage)
    • May require colectomy
    • May be fatal
    • A huge topic in the lay press and certainly will be seized on by the legal community
  • 65. Infection control techniques
    • We all have the power to limit the occurrence of hospital acquired infections
    • Hand washing is the most effective method of limiting hospital acquired infections
  • 66. Infection control techniques
    • Soap and water
    • Hand disinfectant solutions : Steris product, Purell
    • Remember: C-difficile toxin spores are not killed by hand solutions; use soap and water
    • Wear protective gowns and mask when examining c-diff patients
  • 67. EBM in perspective
  • 68. EBM in perspective
    • We have very good data (A)
      • DVT prophylaxis
      • Stress ulcer prophylaxis
      • Spontaneous breathing trials
      • Preventive practices for CR-BSI
  • 69. EBM in perspective
    • We have good data (B), but these studies can likely never be repeated
      • Early goal-directed therapy in septic shock
      • Activated protein-C for severe sepsis
      • Low Vt in ARDS
  • 70. EBM in perspective
    • We have good data (B) that will probably never get better despite further studies
      • Crystalloids vs colloids, albumin
      • Bicarbonate in acidosis
    • We are able to eliminate unproven or potentially unsafe practices
      • NO for ARDS
      • Prone positioning for ARDS
  • 71. EBM in perspective
    • We practice with lots of E’s – these probably can’t ethically be studied
      • Use of antibiotics early in sepsis
      • Draining abscesses
      • Giving fluids for hypovolemia
      • Vasopressors in septic shock
      • Mechanical ventilation in respiratory failure
  • 72. EBM in perspective – the good
    • We know the quality of the data
    • Development of consensus statements
      • ASA, SCCM, ACCP, EAST
      • www.guideline.gov
    • Guidelines and protocols
      • Keep us current and consistent in our care
      • Allows ongoing monitoring of practices
      • Educate our trainees
  • 73. EBM in perspective – the bad
    • Extending data to non-studied or non-proven conditions:
    • Low tidal volumes for all : There is no data that patients who do not have ARDS should be ventilated with low tidal volumes
    • Daily breaks in sedation : It is not reasonable to break sedation in some patients: ARDS, elevated ICP, etc
  • 74. EBM in perspective – the bad
    • Blanket referrals to EBM:
    • PAC usage in critically ill patients : A PAC may still be useful in managing your patient
    • The anti-dopamine conspiracy : Lancet, 2000: 328 patients; 23 ICUs; no effect on renal dysfunction, LOS or mortality
  • 75. EBM in perspective: the bad
    • There are patients with low urine output or impending renal failure secondary to low cardiac output who may benefit from the use of low dose dopamine
  • 76. EBM in perspective – the scary
    • OUTCOMES RELATED TO EVIDENCE-BASED CARE WILL BE MONITORED AND WILL BECOME A MEASURE OF QUALITY AND POTENTIALLY A SOURCE OF MEDICOLEGAL LIABILITY
  • 77. EBM in perspective – keep reading
    • The data may change !!
    • JAMA, July 13, 2005
    • Contradicted findings (16%)
      • Hormone therapy and CAD risk
      • Vitamin E and CAD risk
      • Vit A and breast cancer
      • Monoclonal AB to endotoxin (HA1A)
      • Nitric oxide in ARDS
  • 78. EBM in perspective – keep reading
    • Studies with initially stronger effects (16%)
      • Zidovudine in HIV
      • Angioplasty vs TPA in AMI
      • TPA in CVA
      • CEA and risk reduction of CVA or death
      • Acetylcysteine preventing contrast nephropathy
  • 79. EBM in perspective – reading the literature
    • Cautious use of “the literature”, “landmark” articles
      • It’s easy to quote the last line of the abstract
    • LOOK FOR THE EDITORIAL
      • Comments on the quality and limitations of the study
      • “This study raises more questions than it answers”
      • “Large, randomized trials are needed”
  • 80. Summary
    • We should use EBM consensus statements to keep our knowledge current
    • Reaching the highest rankings (grade A) may be limited by ethics, resource restrictions and marketing strategies
    • Be watchful for “new” data or negation of previously accepted data
  • 81. Summary
    • Realize that the public is watching our adherence to practice guidelines
    • Accept the fact that external monitoring of evidence-based practices and outcomes will be standard in the future
    • Be proactive in maintaining high standards of care