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

Primary Purpose

Pressure Sores, Intensive Care

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Eicosapentanoic acid, docosahexaenoic acid
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Sores focused on measuring intensive care, critically ill, fish oil, pressure sores

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)

Patients in control group will receive nutritional support composed of a standard formula

Outcomes

Primary Outcome Measures

Improvement of wound healing of pressure sores

Secondary Outcome Measures

Improvement in parameters of immunity and inflammation

Full Information

First Posted
June 14, 2007
Last Updated
February 15, 2013
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00487097
Brief Title
The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
Official Title
Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Sores, Intensive Care
Keywords
intensive care, critically ill, fish oil, pressure sores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in control group will receive nutritional support composed of a standard formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Eicosapentanoic acid, docosahexaenoic acid
Other Intervention Name(s)
OXEPA
Intervention Description
Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
Primary Outcome Measure Information:
Title
Improvement of wound healing of pressure sores
Time Frame
within 28 days
Secondary Outcome Measure Information:
Title
Improvement in parameters of immunity and inflammation
Time Frame
Within 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Singer
Organizational Affiliation
Rabin Medical Center, Beilison Hospital, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
22751375
Citation
Theilla M, Schwartz B, Cohen J, Shapiro H, Anbar R, Singer P. Impact of a nutritional formula enriched in fish oil and micronutrients on pressure ulcers in critical care patients. Am J Crit Care. 2012 Jul;21(4):e102-9. doi: 10.4037/ajcc2012187.
Results Reference
derived

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

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