Effects of Fluid Resuscitation With Colloids vs Crystalloids on Mortality in Critically Ill Patients Presenting

With Hypovolemic ShockThe CRISTAL Randomized Trial

!______________, PA-S

Objective

• To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the ICU with hypovolemic shock.

Design• Multicenter RCT stratified by case mix (sepsis, trauma, or

hypovolemic shock without sepsis or trauma).

• Open Label Therapy

• Outcome Assessment was blinded to treatment assignment.

• 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada, b/w 2003 - 2012

InterventionsAll fluid interventions other than fluid maintenance:

• Colloids (n =1414; gelatins, dextrans, hydroxyethyl starches,or 4% or 20% of albumin)

versus

• Crystalloids (n = 1443; isotonic or hypertonic saline or Ringer’s lactate solution)

Measures

• 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• 28-day Mortality: 25.4% in colloids group vs 27.0% in

crystalloids group (P = 0.26)

• 90-day Mortality: 30.7% in colloids group vs 34.2% in crystalloids group (P = 0.03)

• Days alive without mechanical ventilation by 28 days: 14.6 colloids group vs 13.5 crystalloids group (P = 0.01)

• Days alive without vasopressor therapy by 28 days: 16.2 colloids vs 15.2 crystalloids (P = 0.03)

Results• No significant heterogeneity in the effect of treatment

on mortality in any of the predefined strata at 28 days (P = 0.70; Figure 3) or at 90 days (P = 0.84)

Results• No significant heterogeneity in the effect of treatment

on mortality in any of the predefined strata at 28 days (P = 0.70; Figure 3) or at 90 days (P = 0.84)

Conclusions• No difference in 28-day mortality between

crystalloid vs. colloid resuscitation.

• Significantly fewer deaths at 90 days in colloid-resuscitated patients.

• Crystalloid resuscitation may be more efficacious in trauma-related hypovolemic shock.

Critique• Large sample size

• Heterogeneous population and centers

• Zero loss to 90-day follow-up

• Mortality as an outcome limits assesor bias

• Severe Renal Failure excluded • Possible AKI risk with

hydroxyethyl starches

• Variation in Fluid Type Used

• Open-Label

• 9-year Recruitment Period

Djillali Annane, MD, PhD, et. al.

JAMA. 2013;310(17):1809-1817. doi:10.1001/jama.2013.280502.