Scandinavian Intensive Care Unit (ICU) Glutamine Study

Sponsor

Scandinavian Critical Care Trials Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00922714

Collaborator

(none)

1,000

Enrollment

Location

Arms

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICU Patients	Drug: Glutamine Drug: saline (placebo)	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

May 1, 2007

Anticipated Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glutamine Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)	Drug: Glutamine Intravenous glutamine supplementation (0.285 g/kg body weight/24 h) Other Names: L-alanyl-L-glutamine, Dipeptiven
Placebo Comparator: Control saline	Drug: saline (placebo) NaCl 0.9 g/L

Arm

Intervention/Treatment

Experimental: Glutamine

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

Drug: Glutamine

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

Other Names:

L-alanyl-L-glutamine, Dipeptiven

Placebo Comparator: Control

saline

Drug: saline (placebo)

NaCl 0.9 g/L

Outcome Measures

Primary Outcome Measures

A reduction in SOFA-score [Day 7 of treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intensive Care Unit, Karolinska University Hospital Huddinge	Stockholm		Sweden	14186

Sponsors and Collaborators

Scandinavian Critical Care Trials Group

Investigators

Principal Investigator: Jan Wernerman, MD, PhD, Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden