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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515736
Recruitment Status : Terminated (enrollment was completed)
First Posted : August 14, 2007
Last Update Posted : July 30, 2010
Fresenius Kabi
Information provided by:
Centre Hospitalier Universitaire Vaudois

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.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Organ function (SOFA) with special additional attention to renal function [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality [ Time Frame: 3 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
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
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: April 2008

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

Additional relevant MeSH terms:
Critical Illness
Subarachnoid Hemorrhage
Pathologic Processes
Disease Attributes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements
Vitamin B Complex