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

This study has been completed.
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center Identifier:
First received: June 14, 2007
Last updated: February 15, 2013
Last verified: February 2013
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 Intervention
Pressure Sores
Intensive Care
Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Pierre singer, Rabin Medical Center:

Primary Outcome Measures:
  • Improvement of wound healing of pressure sores [ Time Frame: within 28 days ]

Secondary Outcome Measures:
  • Improvement in parameters of immunity and inflammation [ Time Frame: Within 28 days ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: OXEPA
No Intervention: Control Group
Patients in control group will receive nutritional support composed of a standard formula

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00487097

Rabin Medical center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Pierre Singer Rabin Medical Center, Beilison Hospital, Israel
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierre singer, Professor, MD, Rabin Medical Center Identifier: NCT00487097     History of Changes
Other Study ID Numbers: 4428
Study First Received: June 14, 2007
Last Updated: February 15, 2013

Keywords provided by Pierre singer, Rabin Medical Center:
intensive care
critically ill
fish oil
pressure sores

Additional relevant MeSH terms:
Critical Illness
Pressure Ulcer
Disease Attributes
Pathologic Processes
Skin Ulcer
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs processed this record on May 25, 2017