Scandinavian Intensive Care Unit (ICU) Glutamine Study

June 15, 2009 updated by: Scandinavian Critical Care Trials Group

Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Intensive Care Unit, Karolinska University Hospital Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • L-alanyl-L-glutamine, Dipeptiven
Placebo Comparator: Control
saline
Drug: saline (placebo)
NaCl 0.9 g/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A reduction in SOFA-score
Time Frame: Day 7 of treatment
Day 7 of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: ICU stay and 6 months
ICU stay and 6 months
Length of ICU stay
Time Frame: ICU stay
ICU stay
Organ failure free days
Time Frame: ICU stay
ICU stay
Reduction in SOFA-score
Time Frame: Day 10 of treatment
Day 10 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scandinavian Critical Care Trials Group

Investigators

  • Principal Investigator: Jan Wernerman, MD, PhD, Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2007

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Scandinavian Glutamin Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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