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

This study has been completed.
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles Identifier:
First received: September 2, 2005
Last updated: June 29, 2014
Last verified: June 2014

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).

Condition Intervention Phase
Critical Illness Drug: Crystalloids Drug: Colloids Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial

Further study details as provided by Djillali Annane, University of Versailles:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: Day 28 ]

Secondary Outcome Measures:
  • ICU and hospital mortality rates [ Time Frame: Day 90 ]
  • Number of days free of mechanical ventilation (MV), vasopressors, renal replacement therapy, and organ system failure [ Time Frame: Day 90 ]
  • 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 ]
  • Frequency of adverse events [ Time Frame: day 90 ]
  • Length of stay (LOS) [ Time Frame: Day 90 ]

Enrollment: 2857
Study Start Date: February 2003
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Crystalloids, any type of Crystalloids including isotonic or hypertonic saline, Ringer Lactates either modified or not
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: Crystalloids
Any crystalloids given for correction of hypovolemia during all ICU stay
Experimental: 2
Colloids, including albumin, gelatines, starch any other synthetic colloids
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: Colloids
Any colloids given for correction of hypovolemia during all ICU stay

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females, above the legal age of consent
  • Hospitalized in intensive care unit
  • Need fluid resuscitation (according to the physician in charge of the patient)

Exclusion Criteria:

Patients who have one or more of the following items:

  • Known allergy to gelatins, albumin or starch
  • Coagulation disorders (haemophilia, Willebrand disease, etc.)
  • Chronic renal failure on permanent dialysis
  • Severe hepatic failure
  • Burns > 20 % of body surface
  • Pregnancy
  • Volume replacement: As a part of anaesthesia, for anaphylactic shock, or for dehydration
  • Brain death
  • Advance directive of withholding or withdrawal of life-sustaining treatments
  • Any other investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00318942

  Show 67 Study Locations
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
Study Chair: Djillali Annane, MD, PhD Assistance Publique Hôpitaux de Paris - University of Versailles
  More Information

Responsible Party: Djillali Annane, Professor in medicine, University of Versailles Identifier: NCT00318942     History of Changes
Other Study ID Numbers: AOM01020
Study First Received: September 2, 2005
Last Updated: June 29, 2014

Keywords provided by Djillali Annane, University of Versailles:
Multiple Trauma
Hypovolemic Shock

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on September 19, 2017