Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial|
- 28-day mortality [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
- ICU and hospital mortality rates [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
- Number of days free of mechanical ventilation (MV), vasopressors, renal replacement therapy, and organ system failure [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
- Difference in the area under the curve (AUC) of mean arterial pressure (MAP) from HO to H24, in weight gain, in PaO2/FiO2 ratio, chest X-ray score [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
- Frequency of adverse events [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]
- Length of stay (LOS) [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2002|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Crystalloids, any type of Crystalloids including isotonic or hypertonic saline, Ringer Lactates either modified or not
Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stayDrug: Crystalloids
Any crystalloids given for correction of hypovolemia during all ICU stay
Colloids, including albumin, gelatines, starch any other synthetic 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 stayDrug: Colloids
Any colloids given for correction of hypovolemia during all ICU stay
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|Contact: Djillali Annane, MD, PhD||331 47 10 77 firstname.lastname@example.org|
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|Study Chair:||Djillali Annane, MD, PhD||Assistance Publique Hôpitaux de Paris - University of Versailles|