Trials / Completed
CompletedNCT00487097
The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Rabin Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Eicosapentanoic acid, docosahexaenoic acid | Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2007-06-15
- Last updated
- 2013-02-18
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00487097. Inclusion in this directory is not an endorsement.