Scandinavian Intensive Care Unit (ICU) Glutamine Study

This study has been terminated.
(Slow recruitment, stopped after 4 years)
Sponsor:
Information provided by:
Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT00922714
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention Phase
ICU Patients
Drug: Glutamine
Drug: saline (placebo)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Glutamine to Intensive Care Patients - a Prospective, Double-Blind, Placebo-Controlled Multicenter Study in the Scandinavian Countries

Resource links provided by NLM:


Further study details as provided by Scandinavian Critical Care Trials Group:

Primary Outcome Measures:
  • A reduction in SOFA-score [ Time Frame: Day 7 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: ICU stay and 6 months ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Organ failure free days [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Reduction in SOFA-score [ Time Frame: Day 10 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2003
Estimated Study Completion Date: August 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922714

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Jan Wernerman, Karolinska University Hospital Huddinge
ClinicalTrials.gov Identifier: NCT00922714     History of Changes
Other Study ID Numbers: Scandinavian Glutamin Study
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Scandinavian Critical Care Trials Group:
Glutamine
ICU patients
Critically ill
Nutrition

ClinicalTrials.gov processed this record on September 22, 2014