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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00487097
First received: June 14, 2007
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 Rabin Medical Center:

Primary Outcome Measures:
  • Improvement of wound healing of pressure sores [ Time Frame: within 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in parameters of immunity and inflammation [ Time Frame: Within 28 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00487097

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

No publications provided by Rabin Medical Center

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

Keywords provided by 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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014