Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515736
Status:
TERMINATED
Last Update Posted:
2010-07-30
First Post:
2007-08-13
Brief Title:
Impact Of Antioxidant Micronutrients On Intensive Care Unit ICU Outcome
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery Major Trauma And Subarachnoid Hemorrhage Patients
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment was completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Etude-AOX
Brief Summary:
Critically ill patients are generally exposed to an increased oxidative stress which is proportional to the severity of their condition Endogenous antioxidant AOX defenses are depleted particularly in those patients with intense inflammatory response The hypothesis tested is that early IV administration of a combination of AOX micronutrient supplements Se Zn Vit C Vit E Vit B1 would improve clinical outcome in selected critically ill patients by reinforcing the endogenous AOX defenses and reducing organ failure
Detailed Description:
Prospective randomized double-blind placebo-controlled single-center trial Patients admitted to ICU after complicated cardiac surgery major trauma with or without brain injury subarachnoid hemorrhage and predicted by the clinicians to require 48 hours of ICU treatment
Supplements provided IV for 5 days
Supplements provided IV for 5 days
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