Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients

Summary

Background: Two recent systematic reviews of the literature and meta-analyses have suggested that colloids administration might be deleterious in critically ill patients.

Objective: To compare the effects on hospital mortality of crystalloids and colloids when given for fluid resuscitation in critically ill patients.

Setting: Adult intensive care units (ICUs) in several European countries.

Study design: A multinational, randomised, controlled trial performed on two parallel groups.

Intervention: Any type of crystalloids (control group) versus any type of colloids (including albumin).

Patients: All patients above the legal age of consent and hospitalised in an intensive care unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund patients, brain dead patients, and patients who have a known allergy to colloids or severe head injury or major burns (\> 20% of body surface) or dehydration will not be included.

Primary endpoint: 28-day mortality.

Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90% probability (two-sided test).

Conditions

• Critical Illness

Interventions

DRUG

Crystalloids

Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stay

DRUG

Colloids

Gelatines, Albumine, Starch, or any other colloids, at the necessary dose to restore hemodynamic (starch cumulative daily dose should not exceed 35/40 ml/kg), for all ICU stay

DRUG

Crystalloids

Any crystalloids given for correction of hypovolemia during all ICU stay

DRUG

Colloids

Any colloids given for correction of hypovolemia during all ICU stay

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• University of Versailles

  lead OTHER

Principal Investigators

• Djillali Annane, MD, PhD · Assistance Publique Hôpitaux de Paris - University of Versailles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-02-28

Primary Completion

2012-08-31

Completion

2012-11-30

Countries

• Belgium
• Canada
• France
• Tunisia
• United Kingdom

Study Locations