Trial | NCT00515736  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    200
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 Started
Jan 31
2003
Primary Completion
Dec 31
2005
Study Completion
Dec 31
2005
Last Update
Jul 30
2010
Estimate

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

Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg

  • Other names: Selenium - Laboratoire Aguettant, Zinc - Laboratoire Aguettant, the others generic

Drug Placebo

vehicle

  • Other names: vehicle - NaCl 0.9% solution

AOX group Experimental

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 Comparator

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

Criteria 

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
No Results Posted