Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients (REDOXS)

Daren K. Heyland

Status: Completed

Conditions: Multiple Organ Failure; Critical Illness; Sepsis

Treatments: Other: Antioxidants; Other: Glutamine; Other: Glutamine + Antioxidants; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00133978

EudraCT-No: 2007-001831-73

REDOXS

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 1,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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1,223 participants in 4 patient groups, including a placebo group

Glutamine

Experimental group

Description:

Glutamine supplementation

Treatment:

Other: Glutamine

Antioxidants

Experimental group

Description:

Antioxidant supplementation

Treatment:

Other: Antioxidants

Glutamine + Antioxidants

Experimental group

Description:

Glutamine and antioxidant supplementation

Treatment:

Other: Glutamine + Antioxidants

Placebo

Placebo Comparator group

Description:

Non-isonitrogenic, iso-caloric placebo solution

Treatment:

Other: Placebo