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

This study has been terminated.
(enrollment was completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515736
First Posted: August 14, 2007
Last Update Posted: July 30, 2010
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.
Collaborator:
Fresenius Kabi
Information provided by:
Centre Hospitalier Universitaire Vaudois
  Purpose
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 Trauma Subarachnoid Hemorrhage Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

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 ]

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

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
vehicle
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

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT00515736


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

Publications:
Responsible Party: Prof Mette M Berger, MD, PhD, Dept of Adult Intensive Care, CHUV
ClinicalTrials.gov Identifier: NCT00515736     History of Changes
Other Study ID Numbers: CE-102-02
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: July 30, 2010
Last Verified: April 2008

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

Additional relevant MeSH terms:
Hemorrhage
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
Vitamins
Vitamin E
Thiamine
Antioxidants
Selenium
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements
Vitamin B Complex