The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFebruary 18, 2013
February 1, 2013
2.7 years
June 14, 2007
February 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of wound healing of pressure sores
within 28 days
Secondary Outcomes (1)
Improvement in parameters of immunity and inflammation
Within 28 days
Study Arms (2)
Study Group
EXPERIMENTALEnteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)
Control Group
NO INTERVENTIONPatients in control group will receive nutritional support composed of a standard formula
Interventions
Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
Eligibility Criteria
You may qualify if:
- Critically ill patients in intensive care unit
- Grade 2 pressure sores
You may not qualify if:
- Immunosuppression with steroids or other agents
- Active bleeding
- Head trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical center
Petah Tikva, 49100, Israel
Related Publications (1)
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.
PMID: 22751375DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Singer
Rabin Medical Center, Beilison Hospital, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
September 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
February 18, 2013
Record last verified: 2013-02