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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00515736

Acronym

Etude-AOX

Enrollment

200

Registered

2007-08-14

Start date

2003-01-31

Completion date

2005-12-31

Last updated

2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Critically Ill Patients, Subarachnoid Hemorrhage, Trauma

Keywords

selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation

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

Interventions

DRUGSelenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E

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

DRUGPlacebo

vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Organ function (SOFA) with special additional attention to renal function	3 months

Secondary

Measure	Time frame
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality	3 months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026