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

Not Applicable

Completed

• Conditions: Pressure Sores; Intensive Care
• Interventions: Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid

• Registration Number: NCT00487097
• Lead Sponsor: Rabin Medical Center

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 Timeline

• Study First Submitted: 2007-06-14
• Study First Submitted QC: 2007-06-14
• Study First Posted: 2007-06-15
• Study Start: 2007-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Eicosapentanoic acid, docosahexaenoic acid	Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)

Primary Outcome Measures

Name	Time	Method
Improvement of wound healing of pressure sores	within 28 days

Secondary Outcome Measures

Name	Time	Method
Improvement in parameters of immunity and inflammation	Within 28 days

Trial Locations

Locations (1)

Rabin Medical center; 🇮🇱 Petah Tikva, Israel