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Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients

NCT00133978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1223

Last updated 2021-01-07

Study results available
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Summary

The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.

Conditions

  • Critical Illness
  • Sepsis
  • Multiple Organ Failure

Interventions

OTHER

Glutamine

0.35 gm/kg/day parenterally and 30 gms/day enterally

OTHER

Antioxidants

500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally

OTHER

Glutamine + Antioxidants

0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg

OTHER

Placebo

Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)

Sponsors & Collaborators

  • Fresenius Kabi

    collaborator INDUSTRY

  • Daren K. Heyland

    lead OTHER

Principal Investigators

  • Daren Heyland, MD · Clinical Evaluation Research Unit, Kingston General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133978 on ClinicalTrials.gov