Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rabin Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Improvement of wound healing of pressure sores
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study Group
Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)
Intervention: Eicosapentanoic acid, docosahexaenoic acid (Dietary Supplement)
Control Group
Patients in control group will receive nutritional support composed of a standard formula
Outcomes
Primary Outcomes
Improvement of wound healing of pressure sores
Time Frame: within 28 days
Secondary Outcomes
- Improvement in parameters of immunity and inflammation(Within 28 days)
Investigators
Pierre singer
Professor, MD
Rabin Medical Center