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

February 15, 2013 updated by: Pierre singer, Rabin Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of wound healing of pressure sores
Time Frame: within 28 days
within 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in parameters of immunity and inflammation
Time Frame: Within 28 days
Within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 14, 2007

First Submitted That Met QC Criteria

June 14, 2007

First Posted (Estimate)

June 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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