Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133978
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2005-08-22
Brief Title:
Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
Sponsor:
Daren K Heyland
Organization:
Clinical Evaluation Research Unit at Kingston General Hospital
Study Overview
Official Title:
REducing Deaths Due to OXidative Stress The REDOXS Study
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDOXS
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-No 2007-001831-73 | None | None | None |