Scandinavian Intensive Care Unit (ICU) Glutamine Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ICU Patients

Intervention / Treatment
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* Drug: Glutamine
* Drug: saline (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>Intravenous glutamine supplementation (0.285 g/kg body weight/24 h) | Drug: Glutamine<br>* Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)<br>* Other names: L-alanyl-L-glutamine, Dipeptiven;|
| Placebo Comparator: Control<br>saline | Drug: saline (placebo)<br>* NaCl 0.9 g/L<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutamine, ICU patients, Critically ill, Nutrition