Skip to main content
OpenTrials
Completed

NCT Number: NCT00133978

Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Infections Inflammation Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussels, Brussels, Belgium

Loading trial locations.

About this study

Background:

Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial.

Study Intervention:

Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mechanically ventilated patients > or = 18 years old
  • 2 or more organ failures related to acute illness

Exclusion criteria

  • > 24 hours from admission to ICU
  • Patients who are moribund
  • Lack of commitment to aggressive care
  • Absolute contraindication to enteral nutrients
  • Severe acquired brain injury
  • Routine elective cardiac surgery
  • Primary admission of burns > 30% body surface area
  • Weight < 50 kgms or > 200 kgms
  • Pregnant or lactating patients
  • Previous randomization in this study
  • Enrollment in a related ICU interventional study
  • Child's class C liver disease
  • Metastatic cancer with life expectancy < 6 months
  • Seizure disorder requiring anticonvulsant medication

Treatment and study plan

Glutamine

Other

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

Antioxidants

Other

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

Glutamine + Antioxidants

Other

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 names: Dipeptiven, Microselenium/Selenium injection/selenase, EN REDOX formula (from Fresenius Kabi, Germany)

Placebo

Other

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

Primary outcomes

  1. 28-day Mortality

    Time frame: Day 28

    28-day mortality/status: at 28 days after randomization;

Secondary outcomes

  1. ICU Length of Stay

    Time frame: Day 28

    Measure of the duration of participant stay in the ICU

  2. ICU Acquired Infection

    Time frame: Day 28

    We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for 'Definite', 'Probable', and 'Possible' for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.

  3. Hospital Length of Stay

    Time frame: 6 months (from ICU admission)

    Measure of the duration of the participant's hospital stay

Sponsors and collaborators

Lead sponsor

Daren K. Heyland

Other

Collaborators

  • Fresenius Kabi

Registry information

Official study title

REducing Deaths Due to OXidative Stress The REDOXS© Study

Acronym: REDOXS

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Aug 24, 2005
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.