Scandinavian Intensive Care Unit (ICU) Glutamine Study

Phase 4

Terminated

• Conditions: ICU Patients
• Interventions: Drug: Glutamine; Drug: saline (placebo)

• Registration Number: NCT00922714
• Lead Sponsor: Scandinavian Critical Care Trials Group

Brief Summary

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.

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 Timeline

• Study Start: 2003-10
• Primary Completion: 2007-05
• Status Verified: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Last Update Submitted: 2009-06-15
• Study First Posted: 2009-06-17
• Last Update Posted: 2009-06-17
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
Control	saline (placebo)	saline

Primary Outcome Measures

Name	Time	Method
A reduction in SOFA-score	Day 7 of treatment

Secondary Outcome Measures

Name	Time	Method
Mortality	ICU stay and 6 months
Length of ICU stay	ICU stay
Organ failure free days	ICU stay
Reduction in SOFA-score	Day 10 of treatment

Trial Locations

Locations (1)

Intensive Care Unit, Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden