We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    glutamine | Sweden
Previous Study | Return to List | Next Study

Scandinavian Intensive Care Unit (ICU) Glutamine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00922714
Recruitment Status : Terminated (Slow recruitment, stopped after 4 years)
First Posted : June 17, 2009
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
Scandinavian Critical Care Trials Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2003
Actual Primary Completion Date : May 2007
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: L-alanyl-L-glutamine, Dipeptiven
Placebo Comparator: Control
saline
 Drug: saline (placebo)
NaCl 0.9 g/L


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. A reduction in SOFA-score [ Time Frame: Day 7 of treatment ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: ICU stay and 6 months ]
  2. Length of ICU stay [ Time Frame: ICU stay ]
  3. Organ failure free days [ Time Frame: ICU stay ]
  4. Reduction in SOFA-score [ Time Frame: Day 10 of treatment ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922714


Locations
Layout table for location information
Sweden
Intensive Care Unit, Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Scandinavian Critical Care Trials Group
Investigators
Layout table for investigator information
Principal Investigator: Jan Wernerman, MD, PhD Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jan Wernerman, Karolinska University Hospital Huddinge
ClinicalTrials.gov Identifier: NCT00922714    
Other Study ID Numbers: Scandinavian Glutamin Study
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009
Keywords provided by Scandinavian Critical Care Trials Group:
Glutamine
ICU patients
Critically ill
Nutrition