Scandinavian Intensive Care Unit (ICU) Glutamine Study

Scandinavian Critical Care Trials Group

Status and phase: Terminated; Phase 4

Conditions: ICU Patients

Treatments: Drug: saline (placebo); Drug: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00922714

Scandinavian Glutamin Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Description:

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

Treatment:

Drug: Glutamine

Control

Placebo Comparator group

Description:

saline

Treatment:

Drug: saline (placebo)