The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.

Detailed Description
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A prospective randomized study to include 40 consecutive patients admitted to the general intensive care unit. The control group will receive nutritional support composed of a standard formula. The study group will receive nutritional support enriched with fish oil and anti-oxidants. The following variables will be assessed in all patients: demographics, severity of illness, assessment of bed sores. Blood tests will also be taken for the following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7, 14 and 28 after admission. The outcome: improved repair of pressure sores, together with improvement in objective parameters of immunity and inflammation.

Official Title
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Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.

Conditions
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Pressure Sores, Intensive Care

Intervention / Treatment
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* Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients in intensive care unit Grade 2 pressure sores Exclusion Criteria: Immunosuppression with steroids or other agents Active bleeding Head trauma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid) | Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid<br>* Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid<br>* Other names: OXEPA;|
| No Intervention: Control Group<br>Patients in control group will receive nutritional support composed of a standard formula | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of wound healing of pressure sores |  | within 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in parameters of immunity and inflammation |  | Within 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care, critically ill, fish oil, pressure sores