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

Vaud University Hospital Center

Status and phase: Terminated; Phase 3

Conditions: Subarachnoid Hemorrhage; Cardiac Surgery; Trauma; Critically Ill Patients

Treatments: Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00515736

CE-102-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

AOX group

Experimental group

Description:

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)

Treatment:

Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E

0

Placebo Comparator group

Description:

Group receiving vehicle solution for 5 days (double dose for 48 hours)

Treatment:

Drug: Placebo