Status:
COMPLETED
Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ef...
Detailed Description
BACKGROUND Fluid resuscitation is a very common treatment in the ICU, and every day a thousands of critically ill patients are treated around the world with crystalloids or colloids to correct hypovo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
2857 Patients enrolled
Trial Details
Trial ID
NCT00318942
Start Date
February 1 2003
End Date
November 1 2012
Last Update
July 1 2014
Active Locations (67)
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1
Hôpital Erasme
Brussels, Belgium
2
CHU de Sherbrooke-Höpital Fleurimont
Fleurimont, Canada
3
Hôpital Charles LeMoyne
Québec, Canada
4
CH d'Angers
Angers, France