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

This study is not yet open for participant recruitment.
Verified by Rabin Medical Center, June 2007

Sponsored by: 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

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




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