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Scandinavian Intensive Care Unit (ICU) Glutamine Study

This study has been terminated.
(Slow recruitment, stopped after 4 years)
Sponsor:
Information provided by:
Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT00922714
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.


Condition Intervention Phase
ICU Patients
 Drug: Glutamine
Drug: saline (placebo)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries

Resource links provided by NLM:

Drug Information available for: Glutamine
U.S. FDA Resources

Further study details as provided by Scandinavian Critical Care Trials Group:

Primary Outcome Measures:
  • A reduction in SOFA-score [ Time Frame: Day 7 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: ICU stay and 6 months ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Organ failure free days [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Reduction in SOFA-score [ Time Frame: Day 10 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2003
Estimated Study Completion Date: August 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glutamine
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
 Drug: Glutamine
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
Other Name: L-alanyl-L-glutamine, Dipeptiven
Placebo Comparator: Control
saline
 Drug: saline (placebo)
NaCl 0.9 g/L

Detailed Description:

This is a prospective double-blinded placebo-controlled block randomised study in intensive care patients comparing intravenous glutamine supplementation (0.285 g/kg body weight/24 h) to placebo. Inclusion criteria are patients treated for more than 3 days. Primary endpoint is a reduction in SOFA-score on day 7 of treatments. Secondary endpoints are: ICU-mortality, 6-months mortality, length of ICU stay, organ failure free days as well as reduction in SOFA-score on day 10 of treatment. Nutrition will be standardised so that not less than 80% of the target which is basal energy expenditure according to Harris & Benedict is given daily. Enteral nutrition is preferred, but a combination of enteral and parenteral nutrition is recommended to achieve the nutritional target. For statistical comparison non-parametric rank order statistics will be used. To detect a 0.75-point difference in the reduction of SOFA-score on day 7 of treatment, a total of 1,000 patients will be needed.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admission to the ICU
  • decision to give the patient full nutrition
  • APACHE II score > 10 at admission
  • age 18-85 years

Exclusion Criteria:

  • readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
  • subjects with any condition which in the opinion of the attending physician makes the subject unsuitable for inclusion
  • no informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922714

Locations
Sweden
Intensive Care Unit, Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Scandinavian Critical Care Trials Group
Investigators
Principal Investigator: Jan Wernerman, MD, PhD Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Jan Wernerman, Karolinska University Hospital Huddinge
ClinicalTrials.gov Identifier: NCT00922714     History of Changes
Other Study ID Numbers: Scandinavian Glutamin Study
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Scandinavian Critical Care Trials Group:
Glutamine
ICU patients
Critically ill
Nutrition

ClinicalTrials.gov processed this record on May 19, 2013