Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients
CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial
2 other identifiers
interventional
2,857
5 countries
67
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2003
Longer than P75 for phase_3
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 1, 2014
June 1, 2014
9.5 years
September 2, 2005
June 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28-day mortality
Day 28
Secondary Outcomes (5)
ICU and hospital mortality rates
Day 90
Number of days free of mechanical ventilation (MV), vasopressors, renal replacement therapy, and organ system failure
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
Day 2
Frequency of adverse events
day 90
Length of stay (LOS)
Day 90
Study Arms (2)
1
ACTIVE COMPARATORCrystalloids, any type of Crystalloids including isotonic or hypertonic saline, Ringer Lactates either modified or not
2
EXPERIMENTALColloids, including albumin, gelatines, starch any other synthetic colloids
Interventions
Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stay
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Versailleslead
- Assistance Publique - Hôpitaux de Pariscollaborator
Study Sites (67)
Hôpital Erasme
Brussels, Belgium
CHU de Sherbrooke-Höpital Fleurimont
Fleurimont, Canada
Hôpital Charles LeMoyne
Québec, Canada
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
Briançon, France
HIA Percy
Clamart, France
Hôpital A. Beclere
Clamart, France
Hôpital Corbeil Essonnes
Corbeil-Essonnes, France
Hôpital Henri Mondor
Créteil, France
Hôpital Général
Dijon, France
CH Dourdan
Dourdan, France
Centre Hospitalier d'Etampes
Étampes, France
Hôpital de FREYMING-MERLEBACH
Freyming-Merlebach, France
Hôpital Raymond Poincaré
Garches, 92380, France
CHR
La Roche-sur-Yon, France
Hôpital A. Mignot
Le Chesnay, France
CHU Liege
Le Liège, 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
Hôpital Central
Nancy, 54000, France
Hôpital Central NANCY
Nancy, France
Polyclinique de Gentilly
Nancy, France
CHRG d'Orléans
Orléans, France
HEGP
Paris, France
Hôpital Bichat Claude Bernard
Paris, France
Hôpital Bicêtre
Paris, France
Hôpital la Pitié Salpétrière
Paris, France
Hôpital Lariboisière
Paris, France
Hôpital Saint Louis
Paris, France
Hôpital TENON
Paris, France
Hôtel Dieu
Paris, France
CHU de Bordeaux
Pessac, France
Chu Lyon Sud
Pierre-Bénite, France
CHI Poissy
Poissy, France
CHU de Poitiers
Poitiers, France
Centre Hospitalier R. Dubos
Pontoise, France
CH Claude Galien
Quincy-sous-Sénart, 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, 93000, France
CHI Saint Germain en Laye
Saint-Germain-en-Laye, France
CH Mémorial SAINT LO
Saint-Lô, France
CHG de SOISSONS
Soissons, France
Hôpital Civil
Strasbourg, France
Hôpital Hautepierre
Strasbourg, France
CHR Bel Air
Thionville, France
CHU Toulouse
Toulouse, France
CHG Valence
Valence, France
CHU Brabois Nancy
Vandœuvre-lès-Nancy, France
Hôpital T Sfar
Mahdia, Tunisia
Chu Bourguiba
Monastir, Tunisia
Hôpital A Mami
Tunis, Tunisia
Homerton University Hospital
London, United Kingdom
Related Publications (2)
Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declere AD, Preiser JC, Outin H, Troche G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Reignier J, Abroug F, Berger P, Clec'h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. doi: 10.1001/jama.2013.280502.
PMID: 24108515RESULTHeming N, Elatrous S, Jaber S, Dumenil AS, Cousson J, Forceville X, Kimmoun A, Trouillet JL, Fichet J, Anguel N, Darmon M, Martin C, Chevret S, Annane D; CRISTAL Investigators. Haemodynamic response to crystalloids or colloids in shock: an exploratory subgroup analysis of a randomised controlled trial. BMJ Open. 2017 Oct 6;7(10):e016736. doi: 10.1136/bmjopen-2017-016736.
PMID: 28988172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Djillali Annane, MD, PhD
Assistance Publique Hôpitaux de Paris - University of Versailles
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in medicine
Study Record Dates
First Submitted
September 2, 2005
First Posted
April 27, 2006
Study Start
February 1, 2003
Primary Completion
August 1, 2012
Study Completion
November 1, 2012
Last Updated
July 1, 2014
Record last verified: 2014-06