CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,223 enrolled
Drug / intervention
Glutamine +3 moreother
Likely dose
Glutamine 0.35 g/kg/day parenterally and 30 g/day enterally; Antioxidants: selenium 500 mcg/day parenterally plus selenium 300 mcg, zinc 20 mg, beta-carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg/day enterallyAI-extracted
Key inclusion· 2
  • Mechanically ventilated patients 18 years or older
  • 2 or more organ failures related to acute illness
Key exclusion· 10
  • Presentation more than 24 hours after ICU admission
  • Moribund patients
  • Lack of commitment to aggressive care
  • Absolute contraindication to enteral nutrition

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00133978
NCT00133978N/ACompleted

REducing Deaths Due to OXidative Stress The REDOXS© Study

Daren K. Heyland·interventional·Posted Aug 24, 2005·Updated Jan 7, 2021

In Brief

A clinical study evaluating Glutamine, Antioxidants, and 2 other interventions for Critical Illness and 2 related conditions. Completed, enrolled 1,223 participants across 34 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Germany, Switzerland, United States
CollaboratorsFresenius Kabi

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 20.9 years ago

Interventions

Glutamineother

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

Antioxidantsother

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 + Antioxidantsother

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

Placeboother

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