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

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

MedlinePlus related topics:

Antioxidants Pressure Sores

ChemIDplus related topics:

Fish oil Docosahexaenoic acids

U.S. FDA Resources

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.

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	Not yet recruiting
	Petah Tikva, Israel, 49100
	Contact: Pierre Singer, MD +972 3 937 6521 psinger@clalit.org.il
	Contact: Miriam Theilla, RN +972-3-9376524 theilla@012.net.il
	Principal Investigator: Pierre Singer, MD

Sponsors and Collaborators

Rabin Medical Center

Investigators


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

More Information

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

Keywords provided by Rabin Medical Center:

intensive care

critically ill

fish oil

pressure sores

Study placed in the following topic categories:

Skin Diseases

Critical Illness

Ulcer

Skin Ulcer

Pressure Ulcer

Additional relevant MeSH terms:

Disease Attributes

Pathologic Processes

ClinicalTrials.gov processed this record on September 05, 2008

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