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

Study Overview
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Brief Summary
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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
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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

Official Title
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Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients

Conditions
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Critically Ill Patients, Cardiac Surgery, Trauma, Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOX group<br>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<br>* Se 270mcg, Zn 30mg, C 1.1g, B1 100mg, E 300mg<br>* Other names: Zinc - Laboratoire Aguettant, the others generic;|
| Placebo Comparator: 0<br>Group receiving vehicle solution for 5 days (double dose for 48 hours) | Drug: Placebo<br>* vehicle<br>* Other names: vehicle - NaCl 0.9% solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ function (SOFA) with special additional attention to renal function |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, oxidative stress, glutathione peroxidase, critically ill, outcome, supplementation