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NCT00487097 Clinical Trial

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

Intensive Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00487097
Other study ID # 4428
Secondary ID
Status Completed
Phase N/A
First received June 14, 2007
Last updated February 15, 2013
Start date September 2007
Est. completion date May 2010

Study information
Verified date February 2013
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Eicosapentanoic acid, docosahexaenoic acid
Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid

Locations
Country Name City State
Israel Rabin Medical center Petah Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of wound healing of pressure sores within 28 days No
Secondary Improvement in parameters of immunity and inflammation Within 28 days No
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