Chevret S, for the CI. Effects of Fluid Resuscitation With Colloids vs Crystalloids on Mortality in Critically Ill Patients Presenting With Hypovolemic Shock: The CRISTAL Randomized Trial

Raymond Poincaré Hospital, Garches, France.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 10/2013; DOI: 10.1001/jama.2013.280502
Source: PubMed


Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear.Objective
To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock.Design, Setting, and Participants
A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012.Interventions
Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay.Main Outcomes and Measures
The primary outcome was death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy.Results
Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, −0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, −0.04 to 2.10] days; P = .03).Conclusions and Relevance
Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy.Trial Registration Identifier: NCT00318942

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    • "More broadly, initial studies pointed to potential benefits of goal-directed fluid resuscitation early in severe sepsis [14], whereas later aggressive fluid administration during established critical illness appears to be harmful [44-46]. Differences in the time of entry into clinical trials of fluid resuscitation may also explain differing messages about potential harm from colloids used for volume expansion [13,47]. "
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    • "To adequately power a trial to investigate any possible intraoperative harm from HES would need an exceptionally large trial and is unlikely to ever occur. By contrast, the recent publication of the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial, an open-label (clinicians were not blinded to the study fluid) randomized comparison of crystalloids against colloids early during the resuscitation phase of critical illness (i.e., among hypovolemic patients), has suggested a possible benefit for colloids [78]. Similarly, in an animal model, when hemorrhagic shock was induced by the removal of sufficient quantities of blood to obtain and sustain a mean arterial pressure (MAP) of 40 mmHg, restoration of MAP was four times faster with HES than LR (p < 0.001) and required fourfold less volume (p ¼ 0.04) [71]. "
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    • "This recommendation is based on the results of the VISEP5, CRYSTMAS6, 6S7, and CHEST8 trials. The results of the recently completed CRYSTAL trial9 were not considered. CRYSTAL trial results were reviewed separately. "
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