Back to resultsImpact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome (Etude-AOX)
Primary Purpose
Critically Ill Patients, Cardiac Surgery, Trauma
Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Critically Ill Patients focused on measuring selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation
Eligibility 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
Sites / Locations
- Dpt of Adult Intensive Care - CHUV
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AOX group
0
Arm Description
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)
Group receiving vehicle solution for 5 days (double dose for 48 hours)
Outcomes
Primary Outcome Measures
Organ function (SOFA) with special additional attention to renal function
Secondary Outcome Measures
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality
Full Information
NCT ID
NCT00515736
First Posted
August 13, 2007
Last Updated
July 29, 2010
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Fresenius Kabi
1. Study Identification
Unique Protocol Identification Number
NCT00515736
Brief Title
Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
Acronym
Etude-AOX
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
enrollment was completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Fresenius Kabi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients, Cardiac Surgery, Trauma, Subarachnoid Hemorrhage
Keywords
selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AOX group
Arm Type
Experimental
Arm Description
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)
Arm Title
0
Arm Type
Placebo Comparator
Arm Description
Group receiving vehicle solution for 5 days (double dose for 48 hours)
Intervention Type
Drug
Intervention Name(s)
Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
Other Intervention Name(s)
Selenium - Laboratoire Aguettant, Zinc - Laboratoire Aguettant, the others generic
Intervention Description
Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vehicle - NaCl 0.9% solution
Intervention Description
vehicle
Primary Outcome Measure Information:
Title
Organ function (SOFA) with special additional attention to renal function
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette M Berger, MD PhD
Organizational Affiliation
Dpt of Adult Intensive Care, CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Adult Intensive Care - CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18687132
Citation
Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chiolero RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Care. 2008;12(4):R101. doi: 10.1186/cc6981. Epub 2008 Aug 7.
Results Reference
result
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Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
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