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

Sponsor
Rabin Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00487097
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
32
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid
 N/A

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
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)

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

    		•
    No Intervention: Control Group

    Patients in control group will receive nutritional support composed of a standard formula

    Outcome Measures

    Primary Outcome Measures

    1. Improvement of wound healing of pressure sores [within 28 days]

    Secondary Outcome Measures

    1. Improvement in parameters of immunity and inflammation [Within 28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rabin Medical center Petah Tikva Israel 49100

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Pierre Singer, Rabin Medical Center, Beilison Hospital, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pierre singer, Professor, MD, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT00487097
    Other Study ID Numbers:
    • 4428
    First Posted:
    Jun 15, 2007
    Last Update Posted:
    Feb 18, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Pierre singer, Professor, MD, Rabin Medical Center
    intensive care
    critically ill
    fish oil
    pressure sores
    Additional relevant MeSH terms:
    Pressure Ulcer
    Critical Illness

    Study Results

    No Results Posted as of Feb 18, 2013