The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients - Full Text View

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00487097

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 sytems and so improves wound healing.

Condition	Intervention
Pressure Sores Intensive Care	Drug: Ecosopentanoic acid, docosahexaenoic acid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Antioxidants Pressure Sores

Drug Information available for: Docosahexaenoic acids

U.S. FDA Resources

Further study details as provided by 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 ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2008

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 parametere 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:

Immunosupression with steroids or other agents
Active bleeding
Head trauma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487097

Contacts

Contact: Pierre Singer, MD	+972 3 937 6521	psinger@clalit.org.il
Contact: Miriam Theilla, RN	+972 3 937 6524	theilla@012.net.il

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

Study ID Numbers:	4428
Study First Received:	June 14, 2007
Last Updated:	June 14, 2007
ClinicalTrials.gov Identifier:	NCT00487097 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

intensive care
critically ill
fish oil
pressure sores

Additional relevant MeSH terms:

Disease Attributes
Antioxidants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Critical Illness

Physiological Effects of Drugs
Skin Ulcer
Protective Agents
Pressure Ulcer
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009