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

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles
ClinicalTrials.gov Identifier:
NCT00318942
First received: September 2, 2005
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Versailles:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00318942

  Hide Study Locations
Locations
Belgium
Hôpital Erasme
Brussels, Belgium
Canada
CHU de Sherbrooke-Höpital Fleurimont
Fleurimont, Canada
Hôpital Charles LeMoyne
Quebec, Canada
France
CH d'Angers
Angers, France
Centre Hospitalier d'Annecy
Annecy, France
CH Joseph Imbert
Arles, France
CH d'Arpajon
Arpajon, France
CHG de Bastia
Bastia, France
Hôpital Avicenne
Bobigny, France
CH Pellegrin Tripode
Bordeaux, France
Hôpital Cavale Blanche
Brest, France
Chg Briancon
Briancon, France
HIA Percy
Clamart, France
Hôpital A. Beclere
Clamart, France
Hôpital Corbeil Essonnes
Corbeil Essonnes, France
Hôpital Henri Mondor
Creteil, France
Hôpital Général
Dijon, France
CH Dourdan
Dourdan, France
Centre Hospitalier d'Etampes
Etampes, France
Hôpital de FREYMING-MERLEBACH
Freyming Merlebach, France
Hôpital Raymond Poincaré
Garches, France, 92380
CHR
La Roche Sur Yon, France
Hôpital A. Mignot
Le Chesnay, France
CHU Liege
Liege, France
Hôpital Claude Huriez
Lille, France
CH Dupuytren
Limoges, France
Centre Régional Léon Bernard
Lyon, France
Hôpital Louis Pradel
Lyon, France
CH MEAUX
Meaux, France
Hôpital Saint Eloi
Montpellier, France
Centre Hospitalier de Mulhouse
Mulhouse, France
Polyclinique de Gentilly
Nancy, France
Hôpital Central NANCY
Nancy, France
Hôpital Central
Nancy, France, 54000
CHRG d'Orléans
Orléans, France
Hôpital TENON
Paris, France
Hôpital Bicêtre
Paris, France
HEGP
Paris, France
Hôpital Bichat Claude Bernard
Paris, France
Hôtel Dieu
Paris, France
Hôpital Lariboisière
Paris, France
Hôpital la Pitié Salpétrière
Paris, France
Hôpital Saint Louis
Paris, France
CHU de Bordeaux
Pessac, France
Chu Lyon Sud
Pierre Benite, France
CHI Poissy
Poissy, France
CHU de Poitiers
Poitiers, France
Centre Hospitalier R. Dubos
Pontoise, France
CH Claude Galien
Quincy Sous Senart, France
Chu Reims
Reims, France
CHU Rennes
Rennes, France
CH Victor Provo
Roubaix, France
Hôpital Charles Nicolle
Rouen, France
Centre Cardiologique du Nord
Saint Denis, France, 93000
CHI Saint Germain en Laye
Saint Germain en Laye, France
CH Mémorial SAINT LO
Saint Lo, France
CHG de SOISSONS
Soissons, France
Hôpital Hautepierre
Strasbourg, France
Hôpital Civil
Strasbourg, France
CHR Bel Air
Thionville, France
CHU Toulouse
Toulouse, France
CHG Valence
Valence, France
CHU Brabois Nancy
Vandoeuvre Les Nancy, France
Tunisia
Hôpital T Sfar
Mahdia, Tunisia
Chu Bourguiba
Monastir, Tunisia
Hôpital A Mami
Tunis, Tunisia
United Kingdom
Homerton University Hospital
London, United Kingdom
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
  More Information

Publications:
Responsible Party: Djillali Annane, Professor in medicine, University of Versailles
ClinicalTrials.gov Identifier: NCT00318942     History of Changes
Other Study ID Numbers: AOM01020, P010308
Study First Received: September 2, 2005
Last Updated: June 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014