Scandinavian Intensive Care Unit (ICU) Glutamine Study

ICU Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00922714
• Other study ID #: Scandinavian Glutamin Study
• Status: Terminated
• Phase: Phase 4
• First received: June 15, 2009
• Last updated: June 15, 2009
• Start date: October 2003
• Est. completion date: August 2009

Study information

• Verified date: June 2009
• Source: Scandinavian Critical Care Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: August 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ICU Patients

Intervention

Drug:
• Glutamine
Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)
• saline (placebo)
NaCl 0.9 g/L

Locations

Country	Name	City	State
Sweden	Intensive Care Unit, Karolinska University Hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Scandinavian Critical Care Trials Group

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A reduction in SOFA-score		Day 7 of treatment	No
Secondary	Mortality		ICU stay and 6 months	No
Secondary	Length of ICU stay		ICU stay	No
Secondary	Organ failure free days		ICU stay	No
Secondary	Reduction in SOFA-score		Day 10 of treatment	No