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

This study has been terminated.
(enrollment was completed)
Fresenius Kabi
Information provided by:
Centre Hospitalier Universitaire Vaudois Identifier:
First received: August 13, 2007
Last updated: July 29, 2010
Last verified: April 2008
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.

Condition Intervention Phase
Critically Ill Patients
Cardiac Surgery
Subarachnoid Hemorrhage
Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Organ function (SOFA) with special additional attention to renal function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AOX group
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)
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
Placebo Comparator: 0
Group receiving vehicle solution for 5 days (double dose for 48 hours)
Drug: Placebo
Other Name: vehicle - NaCl 0.9% solution

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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00515736

Dpt of Adult Intensive Care - CHUV
Lausanne, VD, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Fresenius Kabi
Principal Investigator: Mette M Berger, MD PhD Dpt of Adult Intensive Care, CHUV
  More Information

Responsible Party: Prof Mette M Berger, MD, PhD, Dept of Adult Intensive Care, CHUV Identifier: NCT00515736     History of Changes
Other Study ID Numbers: CE-102-02
Study First Received: August 13, 2007
Last Updated: July 29, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
oxidative stress
glutathione peroxidase
critically ill

Additional relevant MeSH terms:
Critical Illness
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Disease Attributes
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements processed this record on December 01, 2015