Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients - Full Text View

Sponsors and Collaborators:	University of Versailles Assistance Publique - Hôpitaux de Paris
Information provided by:	University of Versailles
ClinicalTrials.gov Identifier:	NCT00318942

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 III

Drug Information available for: Starch Lactic acid Ammonium lactate Ringer's lactate Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	3010
Study Start Date:	December 2002
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Crystalloids	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
2: Experimental 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

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318942

Contacts

Contact: Djillali Annane, MD, PhD

331 47 10 77 87

djillali.annane@rpc.aphp.fr

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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

Responsible Party:	Assistanca Publique Hôpitaux de Paris - University of Versailles SQY ( Djillali ANNANE )
Study ID Numbers:	AOM01020, P010308
Study First Received:	September 2, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00318942
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Ministry of Health

Keywords provided by University of Versailles:

Sepsis
Multiple Trauma
Hypovolemic Shock

Study placed in the following topic categories:

Multiple Trauma
Sepsis
Shock
Critical Illness
Wounds and Injuries

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009