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

This study is currently recruiting participants.
Verified May 2012 by University of Versailles
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: May 21, 2012
Last verified: May 2012
History of Changes
  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: Open Label
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 ]

Estimated Enrollment: 3010
Study Start Date: December 2002
Estimated Study Completion Date: August 2012
Estimated 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

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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

  Show 72 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
  More Information

No publications provided

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: May 21, 2012
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 May 16, 2013