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

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ClinicalTrials.gov Identifier: NCT00318942
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles

Brief 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).


Condition or disease Intervention/treatment Phase
Critical Illness Drug: Crystalloids Drug: Colloids Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2857 participants
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
Study Start Date : February 2003
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. ICU and hospital mortality rates [ Time Frame: Day 90 ]
  2. Number of days free of mechanical ventilation (MV), vasopressors, renal replacement therapy, and organ system failure [ Time Frame: Day 90 ]
  3. 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 ]
  4. Frequency of adverse events [ Time Frame: day 90 ]
  5. Length of stay (LOS) [ Time Frame: Day 90 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318942


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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Djillali Annane, Professor in medicine, University of Versailles
ClinicalTrials.gov Identifier: NCT00318942     History of Changes
Other Study ID Numbers: AOM01020
P010308
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes