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

Phase 3

Terminated

• Conditions: Critically Ill Patients; Cardiac Surgery; Trauma; Subarachnoid Hemorrhage
• Interventions: Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E; Drug: Placebo

• Registration Number: NCT00515736
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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 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

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-14
• Status Verified: 2008-04
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU

Exclusion Criteria

• absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy < 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOX group	Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E	Treatment group - double dose (loading) for 48 hours then single dose (Se 270 mcg, Zn 30 mg, vit C 1.2 g, B1 100 mg, vit E 300 mg enteral)
0	Placebo	Group receiving vehicle solution for 5 days (double dose for 48 hours)

Primary Outcome Measures

Name	Time	Method
Organ function (SOFA) with special additional attention to renal function	3 months

Secondary Outcome Measures

Name	Time	Method
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality	3 months

Trial Locations

Locations (1)

Dpt of Adult Intensive Care - CHUV; 🇨🇭 Lausanne, VD, Switzerland