Trial | NCT00922714  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    1000
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.
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 Started
Oct 31
2003
Primary Completion
May 31
2007
Study Completion
Aug 31
2009
Anticipated
Last Update
Jun 17
2009
Estimate

Drug Glutamine

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

  • Other names: L-alanyl-L-glutamine, Dipeptiven

Drug saline (placebo)

NaCl 0.9 g/L

Glutamine Experimental

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

Control Placebo Comparator

saline

Criteria 

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
No Results Posted