NCT00515736

Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome

Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
DRUG	Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E	Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
DRUG	Placebo	vehicle

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2007-08-14
• Last updated: 2010-07-30

Locations

1 site across 1 country: Switzerland