Scandinavian Intensive Care Unit (ICU) Glutamine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-08-31

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.

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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.

Conditions

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ICU Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Glutamine

Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)

Group Type EXPERIMENTAL

Glutamine

Intervention Type DRUG

Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)

Control

saline

Group Type PLACEBO_COMPARATOR

saline (placebo)

Intervention Type DRUG

NaCl 0.9 g/L

Interventions

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Glutamine

Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)

Intervention Type DRUG

saline (placebo)

NaCl 0.9 g/L

Intervention Type DRUG

Other Intervention Names

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L-alanyl-L-glutamine, Dipeptiven

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No