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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:
Collaborator:
Fresenius Kabi
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00515736
First received: August 13, 2007
Last updated: July 29, 2010
Last verified: April 2008
History of Changes
  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
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:

U.S. FDA Resources

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
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 13, 2007
Last Updated: July 29, 2010
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Critical Illness
Hemorrhage
Subarachnoid Hemorrhage
Wounds and Injuries
Disease Attributes
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antioxidants
 Ascorbic Acid
Selenium
Vitamin E
Thiamine
Vitamins
Zinc
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Trace Elements
Vitamin B Complex

ClinicalTrials.gov processed this record on June 18, 2013