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

Phase 3TerminatedNCT00515736

Centre Hospitalier Universitaire Vaudois200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

200

Conditions

Critically Ill Patients Cardiac Surgery Trauma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Organ function (SOFA) with special additional attention to renal function

Time frame: 3 months

Secondary Outcomes

Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality