• CRISTAL trial: Colloids vs crystalloids in critically ill patients presenting with hypovolemic shock

    by Alan Batt. Last modified: 10/04/14

    ivfluids

    Summary

    • Multicenter, parallel-group, randomized clinical trial (non-blinded, but outcome assessment was blinded)
    • 6498 ICU patients recruited in 57 ICUs – stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma)
    • 3641 excluded for various reasons
    • 2857 randomised to treatment, 2857 included in analysis (0 lost to follow-up)
      • Control group  – 1443 received crystalloids (isotonic or hypertonic saline or Ringers lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay.
      • Experimental group – 1414 received colloids (gelatins, dextrans, hydroxyethyl starches (HES), or  of albumin) for all fluid interventions other than fluid maintenance throughout the ICU stay.
    • 28 day mortality – lower in experimental group (25.4% vs 27.0%)
    • 90 day mortality – lower in experimental group (30.7% vs 34.2%)
    • RRT use – lower in experimental group (11.0% vs 12.5%)
    • More days alive without mechanical ventilation in by 7 days, and by 28 days in experimental group
    • More days alive without vasopressor therapy by 7 days, and by 28 days in experimental group
    • Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality
    • 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study

    Limitations

    • Non-blinded (open-label) treatments
    • Recruitment period of 9 years
    • Significant exclusion criteria excluded 3641 patients (including 89 “other reasons”)
    • Lower use of RRT in experimental may be due in part to exclusion of chronic renal failure patients, and chloride-rich solution use in control group (i.e. NaCl)
    • More patients in experimental group received blood within first 7 days than control group (26.7% vs 24.8%)
    • There were a significant number of protocol violations (crystalloid group receiving colloids and vice-versa)

     

     
    Annane D1, Siami S, Jaber S, Martin C, Elatrous S, Declère AD, Preiser JC, Outin H, Troché G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Régnier J, Abroug F, Berger P, Clec'h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. PMID: 24108515.

     

    Abstract

    Importance

    Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear.

    Objectives

    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 & 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 Measurements

    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

    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

    clinicaltrials.gov Identifier: NCT00318942.

    References

     
    1.

    Annane D1, Siami S, Jaber S, Martin C, Elatrous S, Declère AD, Preiser JC, Outin H, Troché G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Régnier J, Abroug F, Berger P, Clec’h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. PMID: 24108515.

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    Alan Batt

    Alan Batt

    Paramedic, educator, researcher
    Alan is a critical care paramedic, paramedic educator and prehospital researcher, currently working around the world as an educator and researcher. He has previously worked and studied across Europe, North America and the Middle East. He holds a Graduate Certificate in Intensive Care Paramedic Studies, and an MSc in Critical Care. His main interests are in care of the elderly, end-of-life care, patient safety, professionalism (including role and identity), and paramedic education.

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