Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome — Etude-AOX  

Trauma Clinical Trial

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

Clinical Trial 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 I:V: 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Surgery
• Critical Illness
• Critically Ill Patients
• Hemorrhage
• Subarachnoid Hemorrhage
• Trauma

• NCT number: NCT00515736
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Status: Terminated
• Phase: Phase 3
• Start date: January 2003
• Completion date: December 2005