Colloids: What did we learn last year

"Colloids: What did we learn last year and what
happened in the meantime?"
2nd Fluid Academy Day
Antwerpen 2012
Rainer Gatz
ICU physician
Herlev Hospital
Copenhagen, Denmark

Rainer Gatz, Herlev, Denmark november 2012
2nd Fluid Academy Day Antwerpen 2012
"Colloids: What did we learn last year and what happened in the meantime?"
SwedenDenmark
Ringer's“normal” saline

Bleck Scale of Evidence (BMJ 2000)
Class 0: Things I believe
Class 0a: Things I believe despite the available data
Class 1: Randomised controlled clinical trials that agree with what I
believe
Class 2: Other prospectively collected data
Class 3: Expert opinion
Class 4: Randomised controlled clinical trials that don't agree with what I
believe
Class 5: What you believe that I don't.
Thomas P Bleck
Professor of Neurology, Neurosurgery, and Medicine,
Northwestern University Feinberg School of Medicine

my topics are:
the types of colloids
what we learnt last year
the state of the colloidcrystalloid debate
last year's trials on this subject
ongoing trials
recommendations for future use of starches
all within 15 minutes ......
what we learnt last year
last year's trials on this subject

What did we learn last year?
in the eyes of the coagulation specialist
“6% isooncotic hetastarch is better than gelatin”

“colloids in general are not better than crystalloids in
ICU patients “
“but seem to be better in severe sepsis, cardiac surgery
and liver cirrhosis “

“albumin is better for patients with liver disease“
“and seems to be beneficial in sepsis“

“the last generation starches are perfectly acceptable
and safe “

“looking forward to small volume, hypertonic solutions
with a colloid that is charged “

an acknowledgement!
this work has been done with much inspiration
and information from
the critical care mailing list
ccml
http://www.ccml.org
listowner David Crippen, Pittsburgh, USA

starches and their substitution degrees
0.7 Hetastarch
0.6 Hexastarch
0.5 Pentastarch
0.4 Tetrastarch Voluven® 0.42 Tetraspan®
derived from: maize
potato
gelatins
urealinked gelatin Haemaccel®
succinylated gelatin Gelofusin®
albumin
colloid types

colloid types
source: Association Between a ChlorideLiberal vs ChlorideRestrictive Intravenous Fluid Administration Strategy and Kidney Injury in Critically Ill Adults
Yunos et alii, JAMA 2012;308(15):15661572
SID (mEq/l) 0 29 34 50 12 81
(without metabolisable anions)

colloid types
albumin
just a reminder: this is not a completely pure
product, completely identical to the natural
thing
produced by ethanol fractionation and
chromatography
undergoes a virus inactivation process
contains impurities:
protein aggregates and prekallikrein activator
contains additives: octanoate

ff
albumin a 1953 tracer study
Tracer Experiments With I181 Labeled Human Serum Albumin: Distribution And Degradation Studies
Solomon A. Berson et alii, J Clin Invest., 1953, 746768
plasma
vessel rich
vessel poor
60%

albumin a 1953 tracer study
Tracer Experiments With I181 Labeled Human Serum Albumin: Distribution And Degradation Studies
Solomon A. Berson et alii, J Clin Invest., 1953, 746768
"The apparent space of distribution in nonascitic subjects
averaged about 2.5 times the plasma volume.
Two apparent rates of
transfer between plasma and extravascular spaces
with half times of approximately 3 and 24 hours, were observed."

albumin transmembrane transport
albondin
Albondinmediated capillary permeability to albumin
Schnitzer JE, Oh P
J Biol Chem 1994 Feb 25;269(8):607282
"About 50% of albumin transport is dependent on binding to the
endothelial cell surface glycoprotein, albondin.
The remaining, binding and concentrationindependent
transport could occur through intercellular junctions and/or
fluidphase transport via vesicular transcytosis and/or
transendothelial channels."
albumin transmembrane transport
albondin

albumin
genetically determined analbuminaemia
Analbuminemia: Three cases resulting from different point mutations in the albumin gene
Proc. Nati. Acad. Sci. USA Vol. 91, pp. 94179421, September 1994
Scott Watkins, Jeanne Madison, Monica Galliano, Lorenzo Minchiotti, and Frank W. Putnam
"Analbuminemia was reported in a 39yrold Italian man ....
Analysis by rocket electrophoresis gave a serum albumin value of
5 mg/dl. The subject did not exhibit edema and was essentially
asymptomatic."
"Analbuminemia was reported in a 39yrold Italian man ....
Analysis by rocket electrophoresis gave a serum albumin value of
5 mg/dl. The subject did not exhibit edema and was essentially
asymptomatic."

october 2011 EARSS, first results at ESICM
january 2012 Simon et alii, two hit model of renal damage
january 2012 Saw et alii, gelatin metaanalysis
february 2012 Muller et alii, HES and renal dysfunction
march 2012 ThomasRueddel et alii, gelatin metaanalysis
may 2012 CRYSTMAS trial  *
june 2012 6S trial
june 2012 BaSES trial, first results at ESA
july 2012 PAL pilot study  *
august 2012 Bayer, colloids or crystalloids in shock reversal
october 2012 CHEST trial
october 2012 Albios study, first results at ESICM
october 2012 Yunos et alii, chloride effect
* results already communicated at last year's fluid academy day
june 2012 6S trial
last year's developments a timeline
june 2012 6S trial

what DOES a clinician want to know?
mortality
morbidity
renal injury and failure
amount of bleeding
amount of fluid needed for primary resuscitation
cumulative fluid balance

The EARSS study
results as communciated at ESICM in Berlin, october 2011
NCT00327704
Early Albumin Resuscitation during Septic Shock
Julien Charpentier, Jean Paul Mira, Hôpital Cochin, Paris

The EARSS study
type of trial:
  prospective, multicentre, randomised, open clinical trial
eligible patients:
  septic shock of up to 6 hours duration
type of intervention:
  albumin versus 0.9% NaCl
   control group: 0.9% NaCl 100 ml /8h for 3 days
   albumin group: albumin 20% 20 g/8h for 3 days
primary outcome measure:
  28 and 90 days mortality
secondary outcome measures:
  SOFA scores
  ICU and hospital length of stay
  incidence of renal failure and pulmonary oedema
type of trial:
  prospective, multicentre, randomised, open clinical trial
eligible patients:
  septic shock of up to 6 hours duration
  albumin versus 0.9% NaCl
   control group: 0.9% NaCl 100 ml /8h for 3 days
   albumin group: albumin 20% 20 g/8h for 3 days
  28 and 90 days mortality
  SOFA scores
  incidence of renal failure and pulmonary oedema

The EARSS study
number of patients included:
  399 albumin group
  393 control group
primary outcome results:
  28 days mortality:
    albumin group: 24.1%
    control group: 26.3%
P=0.43
    subgroups:
      community acquired infection
      difference albumin versus control group P=0.29
      nosocomial infection
      difference albumin versus control group P=0.85
  90 days mortality
    albumin group: 34.7%
    control group: 35.1%

The EARSS study
secondary outcome results:
  ICU length of stay
P=0.61
  hospital length of stay
P=0.45
  incidence of renal failure oedema
    number with renal replacement therapy and creatinin levels
virtually identical between both groups
  free of mechanical ventilation within 28 days: P=0.24

The EARSS study
quote from the presentation at ESICM Berlin
"3 days hyperoncotic albumin administration is well tolerated"

Simon et alii, two hit model of renal damage

type of trial:
  prospective randomised animal experiment
eligible patients:
  none, study done in 23 pigs
  shamtreated group versus group with twohit model
combining haemorrhagic and septic shock
outcome measure:
  renal function and inflammatory response

creatinine clearance, ml/min, 12 hours after sepsis:
    Ringer's acetate: 76 ± 23
    6% HES 130/0.42 in acetate: 97 ± 15
    10% HES 200/0.5: 13 ± 14 (significant)
    4% gelatin in acetate: 38 ± 8
(significant)
    sham treated: 98 ± 48
  fluid balance, ml/kg BW, 12 hours after sepsis:
    335 ± 94 in the Ringer's treated group versus 70 to 150 in the
other groups (P< 0.05)
  creatinine clearance, ml/min, 12 hours after sepsis:
    Ringer's acetate: 76 ± 23
    6% HES 130/0.42 in acetate: 97 ± 15
    10% HES 200/0.5: 13 ± 14 (significant)
    4% gelatin in acetate: 38 ± 8
(significant)
    sham treated: 98 ± 48
  histology, acute tubular necrosis score:
    Ringer's acetate: 0.8 ± 0.3
    6% HES 130/0.42 in acetate: 1.8 ± 1.1
    10% HES 200/0.5: 2.2 ± 0.4 (significant)
    4% gelatin in acetate: 2.6 ± 0.5 (significant)
    sham treated: 0.3 ± 0.6
  histology, acute tubular necrosis score:
    Ringer's acetate: 0.8 ± 0.3
    6% HES 130/0.42 in acetate: 1.8 ± 1.1
    10% HES 200/0.5: 2.2 ± 0.4 (significant)
    4% gelatin in acetate: 2.6 ± 0.5 (significant)
    sham treated: 0.3 ± 0.6

Saw et alii, gelatin metaanalysis

type of trial:
  metaanalysis
  (studies using randomisation, no crossover,  with comparison of gelatin use to that of crystalloids or
other colloids including isotonic albumin, but not other blood products)
eligible patients:
  patients in perioperative and critical care settings
  30 randomised controlled trials involving 2709 patients,
primary endpoint available in 14 studies with 1788 patients
  hospital mortality, alternatively 28day mortality
  incidence of acute renal failure
  total blood loss during study periods
  volume of blood transfused
  incidence of allergic reactions
type of trial:
  metaanalysis
  (studies using randomisation, no crossover,  with comparison of gelatin use to that of crystalloids or
other colloids including isotonic albumin, but not other blood products)
eligible patients:
  patients in perioperative and critical care settings
  30 randomised controlled trials involving 2709 patients,
primary endpoint available in 14 studies with 1788 patients
  hospital mortality, alternatively 28day mortality
  incidence of acute renal failure
  total blood loss during study periods
  volume of blood transfused
  incidence of allergic reactions

primary outcome result:
risk of mortality:
gelatin versus all other types of fluids:
(odds ratio 1.03, 95% confidence interval 0.80 to 1.32)
not significantly different

   amount of blood lossed:
    19 studies with 1252 patients report this
    no significant differences
   amount of blood transfused:
     gelatin versus all other types of fluids
     gelatin versus crystalloids
      weightedmeandifference 180 ml
95% CI 8 to 354 ml   significant
   incidence of acute renal failure:
    in the subgroup of gelatin versus HES treatment there were fewer cases of acute renal failure
in the gelatin group, but the comparison was mainly with HES 200

concerns / comments:
"The quality of the published studies on gelatin solutions was
also unsatisfactory, with no study having both adequate
allocation concealment and doubleblinding."

ThomasRueddel et alii, gelatin metaanalysis

40 RCTs published between 1976 and 2010
patients receiving gelatin for resuscitation in comparison to
albumin or crystalloids
3275 patients included

"No study was adequately powered to investigate the
frequency of patientimportant outcomes."
"Despite over 60 years of clinical practice, the safety and
efficacy of gelatin cannot be reliably assessed in at least some
settings in which it is currently used."

Muller et alii, Fluid management and risk factors for
renal dysfunction

renal dysfunction
type of trial:
  observational multicenter study in 15 Southern French ICUs,
two periods
eligible patients:
  patients without a history of renal failure and treated for
severe sepsis and septic shock surviving after 24 hours
  intervention based on the Surviving Sepsis Campaign in the
second period
  factors associated with renal dysfunction and renal
replacement therapy
  388

renal dysfunction
  factors independently associated with renal dysfunction:
male gender
increase in SAPS II scores
being a surgical patient
no decrease in SOFA scores during the first 24 hours
being treated during the interventional period of the study
  factors independently associated with renal replacement therapy:
need for vasopressors
baseline value of plasma creatinine
  mortality rate in patients with renal dysfunction versus in those
without renal dysfunction (48% versus 24%, P < 0.01)
  mortality rate in patients requiring RRT 52% versus 26% in those
not requiring RRT (P < 0.01)

renal dysfunction
Use of colloids
315 of 388 patients received colloids
association with renal dysfunction (no versus yes):
185 (78%) versus 101 (86%) P=0.07
association with renal replacement therapy (no versus yes):
241 (81%) versus 74 (82%) P=0.82
“Despite being used in more than 80% of patients with severe sepsis
and/or septic shock, the administration of HES 130/0.4 in the first 24
hours of management was not associated with the occurrence of renal
dysfunction.”

The CRYSTMAS study

The CRYSTMAS study
type of trial:
  randomised, prospective, multicenter, activecontrolled,
doubleblind
eligible patients:
  patients with severe sepsis requiring fluid resuscitation in
several French and German ICUs
  HES 6% (130/0.4) (Voluven®) versus NaCl 0.9% to
haemodynamic stability
  amount of fluid to achieve haemodynamic stability
type of trial:
  randomised, prospective, multicenter, activecontrolled,
doubleblind
eligible patients:
  patients with severe sepsis requiring fluid resuscitation in
several French and German ICUs
  HES 6% (130/0.4) (Voluven®) versus NaCl 0.9% to
haemodynamic stability

The CRYSTMAS study
  time to achieve haemodynamic stability
  mortality
  total quantity of study drug infused over four consecutive days
  area under the curve of SOFA score
  acute renal failure
  196 randomised, 174 (88 / 86) with complete datasets
  time to achieve haemodynamic stability
  mortality
  total quantity of study drug infused over four consecutive days
  area under the curve of SOFA score
  acute renal failure
  196 randomised, 174 (88 / 86) with complete datasets

The CRYSTMAS study
     HES 1400 ±  890ml
     NaCl 0.9% 1700 ±1200ml
    (mean difference =   331 ±1033ml, 95% CI 21 to 640ml, P =
0.02)
==> ratio crystalloid to colloid needed to achieve the same
haemodynamic goals:
1.21
SAFE trial: 1.4, VISEP 1.6 (day 1), FIRST trial 1.4
     HES 1400 ±  890ml
     NaCl 0.9% 1700 ±1200ml
    (mean difference =   331 ±1033ml, 95% CI 21 to 640ml, P =
0.02)

The CRYSTMAS study
  time to achieve haemodynamic stability:
   HES 11.8 ±10.1 hours
   NaCl 0.9% 14.3 ±11.1 hours
   (difference not significant)
  acute renal failure
   24 (25%) and 19 (20%) patients for HES and NaCl,
respectively (P = 0.454)
   no difference between AKIN and RIFLE criteria
  no significant difference in ICU and hospital length of stay, total quantity of
study drug infused over four consecutive days or area under the curve of SOFA
score
  no difference in mortality, coagulation, transfusion requirement, incidence of
infections or pruritus up to 90 days after treatment initiation

The 6S study
Scandinavian Starch for Severe Sepsis / Septic Shock
NEnglJMed 2012; 367:124134
130/0.42

type of trial:
  investigatorinitiated, multicenter, parallelgroup, blinded
trial, randomised, in Denmark, Norway, Finland, and Iceland
eligible patients:
  patients with severe sepsis
  fluid resuscitation in the ICU with either 6% HES 130/0.42 or
Ringer's acetate at a dose of up to 33 ml per kilogram of ideal
body weight per day
  was either death or endstage kidney failure (dependence on
dialysis) at 90 days after randomization
The 6S study
type of trial:
  investigatorinitiated, multicenter, parallelgroup, blinded
trial, randomised, in Denmark, Norway, Finland, and Iceland
eligible patients:
  fluid resuscitation in the ICU with either 6% HES 130/0.42 or
Ringer's acetate at a dose of up to 33 ml per kilogram of ideal
body weight per day
  was either death or endstage kidney failure (dependence on
dialysis) at 90 days after randomization

The 6S study
  death at 28 days
  death at the time of the latest followup assessment
  severe bleeding while the patient was in the ICU
  severe allergic reactions
  SOFA score at day 5 after randomization
  the development of acute kidney injury
  doubling of the plasma creatinine level in the ICU
  acidosis (arterial pH <7.35) in the ICU
  percentage of days alive without renalreplacement therapy
  days alive without mechanical ventilation
  days alive out of the hospital in the 90 days after
randomization

The 6S study
planned subgroup analyses:
  patients with shock at the time of randomisation
  patients with acute kidney injury at the time of
randomisation
type of analysis:
  modified intentiontotreat
statistical power:
  800 patients needed for the study to have 80% power to show
an absolute betweengroup difference of 10 percentage points
in the primary outcome measure
  and a 5% rate of dependence on dialysis at 90 days
  804 patients underwent randomisation, 798 were included
  patients with shock at the time of randomisation
  patients with acute kidney injury at the time of
randomisation
type of analysis:
  modified intentiontotreat
statistical power:
  800 patients needed for the study to have 80% power to show
an absolute betweengroup difference of 10 percentage points
in the primary outcome measure
  and a 5% rate of dependence on dialysis at 90 days
  804 patients underwent randomisation, 798 were included

The 6S study
“Trial fluid (6% HES 130/0.42 in Ringer's acetate (Tetraspan
6%®, B. Braun) or Ringer's acetate (Sterofundin ISO®, B.
Braun)”
SID (without metabolisable anions) 29 mEq/l

The 6S study
primary outcome result:

death at 90 days:
    HES 130/0.4: 201 of 398 patients (51%)
    Ringer's acetate: 172 of 400 patients (43%)
     relative risk, 1.17
     95% confidence interval (CI), 1.01 to 1.36; P = 0.03

The 6S study

The 6S study
secondary outcome results
   renalreplacement therapy:
      HES 130/0.4: 87 patients (22%)
      Ringer's acetate: 65 patients (16%)
     (relative risk, 1.35; 95% CI, 1.01 to 1.80; P = 0.04)
   severe bleeding:
      HES 130/0.4: 38 patients (10%)
   renalreplacement therapy:
      HES 130/0.4: 87 patients (22%)
   severe bleeding:
      HES 130/0.4: 38 patients (10%)

The 6S study
relative risks with 95% confidence intervals (CIs)
for the primary outcome of death or dependence on dialysis at day 90,
among all patients and in the two predefined subgroups

Fluid Therapy before and after Randomisation
The 6S study

The 6S study
source: http://www.nejm.org/doi/full/10.1056/NEJMoa1204242

The 6S study
source: http://uk.finance.yahoo.com/
Fresenius share prices

The 6S study
source: http://uk.finance.yahoo.com/

Basel Starch Evaluation in Sepsis
type of trial:
  doubleblind, randomised, controlled monocentric study
eligible patients:
  240 consecutive patients with sepsis, severe sepsis and
septic shock
  volume therapy with Ringer's lactate and saline or HES
130/0.4 in the first five days of intensive care treatment

  intensive care length of stay
  mortality
  kidney function

Bayer et alii, colloids or crystalloids in shock reversal

type of trial:
  single centre, prospective before and after study
comparing three different treatment periods (not
randomised, sequential groups)
eligible patients:
  consecutive patients with severe sepsis
  fluid therapy directed at preset haemodynamic goals with
   HES (predominantly 6% hydroxyethyl starch 130/0.4) in
the first period
   4% gelatin in the second period
   only crystalloids in the third period

primary outcome measures:
  time to shock reversal (serum lactate <2.2 mmol/l and
discontinuation of vasopressor use)
  required fluid volumes in patients with septic shock
  acute kidney injury (defined by RIFLE criteria)
  new need for renal replacement therapy
  ICU length of stay
  hydroxyethyl starch: 360
  gelatin: 352
  only crystalloids: 334

  all groups showed similar time to shock reversal
  more fluid was needed over the first 4 days in the
crystalloid group:
  fluid ratio 1.4:1 crystalloids to HES
1.1:1 crystalloids to gelatin

  Total fluids day 1 to 4, in ml/kg:
     HES 205 (156 267) (versus crystalloid
P<0.01)
     gelatin 224 (176 305)
     crystalloid 239 (171 314)
  after day 5, fluid balance was
  more negative in the crystalloid group
    Total fluids day during ICU stay, in ml/kg:
     HES 790 (355 1512) (versus crystalloid
P<0.001)
     gelatin 631 (276 1091) (versus crystalloid
P<0.001)

  intensive care unit length of stay (in days):
     HES 18 (8 30) (versus crystalloid P<0.001)
     gelatin 13 (6 24) (versus crystalloid P<0.001)
     crystalloid 10 (4 18)
  Acute kidney injury by RIFLE (number and %):
     HES 254 (71) (versus crystalloid P<0.001)
     gelatin 238 (68) (versus crystalloid P=0.014)
     crystalloid 195 (58)

  no significant differences for:
     ICU or hospital mortality
     mean and maximum SOFA scores

concerns / comments:
24,326 surgical ICU patients were screened, 23,280
patients met exclusion criteria, including a total of 1,046
patients with severe sepsis or septic shock
exclusion criteria
< 18 years
solid organ transplantation
renal failure requiring haemodialysis before ICU
extracorporeal membrane oxygenation
serum creatinine values missing at admission
admission during the 1 month washout period between
changes in resuscitative fluid regimens

The CHEST study
N Engl J Med, October 2012 DOI: 10.1056/NEJMoa1209759

Stephen Streat on ccml, 20120321:
(intensivist, Auckland, New Zealand)
The protocol was published in ICM in January 2011.
This was a 7000patient trial which finished recruitment on 23rd January
2012 on schedule.
It was done in 18 months, at an average recruitment rate of 75 patients per
week.
There was only a 2.9% loss to followup, mainly due to withdrawal of
consent, and an 11% protocol violation rate.
The study involved the administration of 4 million mls of fluids in 47720
bags of fluid!
Tertiary outcomes (health economics etc.) will be analysed in 2013.
Then they plan to followup practice with 'CHESTTRIPS' in 2014.
Stephen Streat on ccml, 20120321:
(intensivist, Auckland, New Zealand)
The protocol was published in ICM in January 2011.
This was a 7000patient trial which finished recruitment on 23rd January
2012 on schedule.
It was done in 18 months, at an average recruitment rate of 75 patients per
week.
There was only a 2.9% loss to followup, mainly due to withdrawal of
consent, and an 11% protocol violation rate.
The study involved the administration of 4 million mls of fluids in 47720
bags of fluid!
Tertiary outcomes (health economics etc.) will be analysed in 2013.
Then they plan to followup practice with 'CHESTTRIPS' in 2014.
The CHEST study

The CHEST study
type of trial:
  prospective, multicentre, concealed, randomised controlled trial
eligible patients:
  7000 patients planned to be recruited from 32 intensive care
unit throughout Australia and New Zealand
  all pts admitted to the ICU and needing fluids, according to the
treating physician, no strict treatment protocol
  6% HES (130/0.4) versus 0.9% sodium chloride for intravascular
volume resuscitation in the Intensive Care Unit
type of trial:
  prospective, multicentre, concealed, randomised controlled trial
eligible patients:
  7000 patients planned to be recruited from 32 intensive care
unit throughout Australia and New Zealand
  all pts admitted to the ICU and needing fluids, according to the
treating physician, no strict treatment protocol
  6% HES (130/0.4) versus 0.9% sodium chloride for intravascular
volume resuscitation in the Intensive Care Unit

The CHEST study
  90day allcause mortality
  mortality in predefined subgroups
  incident renal failure (RIFLE criteria)
  Sequential Organ Failure Assessment (SOFA) score
  use of renal replacement therapy
  other organ failures (measured using SOFA)
  ICU mortality
  hospital mortality
  length of ICU stay
  quality of life assessment measured using EQ5D score
  in patients with traumatic brain injury, functional outcome
measured using the Glasgow Outcome Score
  90day allcause mortality
  mortality in predefined subgroups
  incident renal failure (RIFLE criteria)
  Sequential Organ Failure Assessment (SOFA) score
  use of renal replacement therapy
  other organ failures (measured using SOFA)
  ICU mortality
  hospital mortality
  length of ICU stay
  quality of life assessment measured using EQ5D score
  in patients with traumatic brain injury, functional outcome
measured using the Glasgow Outcome Score

The CHEST study
  patients admitted for trauma with traumatic brain injury
  patients admitted for trauma without traumatic brain injury
  patients with preexisting chronic renal failure in the absence of
oliguria or anuria
type of analysis:
  intentiontotreat
statistical power:
  90% power to detect an absolute difference of ≥3.5% in mortality
  90% power to detect a relative risk increase of renal failure by 1.5
  7000

The CHEST study

The CHEST study
primary outcome result
90day allcause mortality:
HES group: 597 of 3315 (18.0%)
saline group: 566 of 3336 (17.0%)
(relative risk in the HES group, 1.06
95% confidence interval, 0.96 to 1.18; P=0.26

The CHEST study
primary outcome results

The CHEST study

The CHEST study
source: supplement at http://www.nejm.org

The CHEST study
controversy on ccml!
Hohum elderly patients in first world ICUs don't differ whether
treated with crystalloid or colloid. Still want to know how to apply
this to a 25 year old with a 3 day
old perf appendix or in a 25 year old who blows up like a Michelin
Man on Ringer's but maintains normal body weight (and most other
parameters) on starch (or gelatin back in the day).
Eric
intensivist, Durban, South Africa
De: Eric Hodgson
Para: International Critical Care Medicine Group
<ccml@list.pitt.edu>

The CHEST study
controversy on ccml!
I see such patients and don't use HES and they don't bloat.You are
overtreating with crystalloids in that case. 1 liter of HES cannot
miraculously make a patient less bloaty.
Prasanna
thoracic surgeon, Bangalore, India
answer by Prasanna, ccml, 20121017:
De: Prasanna Simha
Para: International Critical Care Medicine Group
<ccml@list.pitt.edu>

The Albios study
Efficacy of Albumin Administration for Volume Replacement
in Patients With Severe Sepsis or Septic Shock
the ALBumin Italian Outcome Sepsis (ALBIOS) Study

The Albios study
type of trial:
  interventional, randomised, open label
eligible patients:
  severely septic and septic shock patients admitted to ICU
  albumin to plasma level of >=30g/l versus crystalloid
infusion, to predefined haemodynamic goals according to the
earlygoal directed therapy
  (infusion of other colloids was not allowed)
type of trial:
  interventional, randomised, open label
eligible patients:
  severely septic and septic shock patients admitted to ICU
  albumin to plasma level of >=30g/l versus crystalloid
infusion, to predefined haemodynamic goals according to the
earlygoal directed therapy
  (infusion of other colloids was not allowed)

The Albios study
  28day, 90day survival
  number and severity of organ dysfunction (as recorded by the
SOFA score)
  hospital and intensive care unit (ICU) length of stay
  1815 patients, interim analysis of DSMB advised to continue
after 1300 patients
  908 in the albumin, 907 in the crystalloid group
  28day, 90day survival
  number and severity of organ dysfunction (as recorded by the
SOFA score)
  hospital and intensive care unit (ICU) length of stay
  1815 patients, interim analysis of DSMB advised to continue
after 1300 patients
  908 in the albumin, 907 in the crystalloid group

The Albios study
  (no final results yet; only results till hospital discharge)
  mortality at hospital discharge:
   36% for the albumin group, 37% for the crystalloid group
  (no significant difference)
  not available yet

The Albios study
comment on ccml, 20121017
Septic shock has a trend to low mortality with albumin
(p=0.056). We will have to wait for final results.
Murillo Santucci Cesar de Assunção
São Paulo, Brasil

JAMA 2012;308(15):15661572

“Conclusion:
The implementation of a chloriderestrictive strategy in a
tertiary ICU was associated with a significant decrease in the
incidence of AKI and use of RRT.”
0.7 l of gelatin per patient in the control period, no artificial
colloids administered during the intervention period 154 / 120
possible confounders:
succinylated gelatin (as used in this study) contains Na / Cl
154 / 120 mmol/l, is thus naturally "balanced"

open studies
CRISTAL study
Efficacy and Safety of Colloids Versus Crystalloids for Fluid
Resuscitation in Critically Ill Patients
NCT00318942
BaSES trial
NCT00273728
RASP trial
Lactated Ringer Versus Albumin in Early Sepsis Therapy
NCT01337934
Efficacy and Safety of Colloids Versus Crystalloids for Fluid
Resuscitation in Critically Ill Patients
NCT00318942
and many, many more ....
http://www.clinicaltrials.gov

Consensus statement of the ESICM task force on colloid volume
therapy in critically ill patients
Konrad Reinhart, Anders Perner, Charles L. Sprung, Roman
Jaeschke, Frederique Schortgen, A. B. Johan Groeneveld, Richard
Beale and Christiane S. Hartog
Intensive Care Medicine Volume 38, Number 3 (2012), 368383
We recommend not to use HES with molecular weight >=200 kDa and/or degree of substitution >0.4 in
patients with severe sepsis or risk of acute kidney injury
and suggest not to use 6% HES 130/0.4 or gelatin in these populations.
We recommend not to use colloids in patients with head injury and
not to administer gelatins and HES in organ donors.
We suggest not to use hyperoncotic solutions for fluid resuscitation.
We conclude and recommend that any new colloid should be introduced into clinical practice only
after its patientimportant safety parameters are established.

my two conflicts of interest
http://www.acidbase.org/fluidacademy/

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