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Oxepa in Multiple Trauma (OMT)

This study is currently recruiting participants.
Verified February 2013 by Rabin Medical Center
Sponsor:
Collaborator:
Israeli Ministry of Security
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01099501
First received: April 1, 2010
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.

The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.


Condition Intervention Phase
Multiple Trauma
Head Trauma
 Dietary Supplement: Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
Dietary Supplement: oxepa
Dietary Supplement: Control group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Oxygenation (PO2/FIO2 ratio) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)


Secondary Outcome Measures:
  • TNF-α, CRP (markers of inflammatory response) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Concentration of circulating inflammatory markers: TNF-α, CRP concentrations

  • Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Fatty acid composition of RBC membrane (thin liquid chromatography)


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxepa
Oxepa (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
 Dietary Supplement: Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding
Dietary Supplement: oxepa
A dose determined by a patient's energy expenditure and tolerance of enteral feeding.
Active Comparator: Control group
Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
 Dietary Supplement: Control group
Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged 18-90 years with multiple-trauma or head trauma admitted to the ICU.
  2. Enteral nutrition can be initiated within 36 hours of admission/ injury.
  3. Mechanical ventilation.

Exclusion criteria:

  1. Severe underlying systemic disease and /or treatment with immunosuppressive agents.
  2. Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
  3. 2nd /3rd degree burns covering > 66% BSA.
  4. Pregnancy.
  5. Participants under the age of 18.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099501

Contacts
Contact: Pierre Singer, Principal Investigator MD 972-3-9376521 psinger@clalit.org.il

Locations
Israel
Rabin Medical Center, Campus Beilinson Recruiting
Petach Tikva, Israel, 49100
Contact: Pierre Singer, MD     972-39376521     psinger@clalit.org.il    
Contact: Milana Grinev, Study Coordinator     972-39376521     milang@clalit.org.il    
Sub-Investigator: Shaul Lev, MD            
Sub-Investigator: Ilya Kagan, MD            
Sub-Investigator: Miriam Ben Harosh Katz, MD            
Sub-Investigator: Milana Grinev, RN            
Sub-Investigator: Miriam Theilla, RN, MSC            
Sub-Investigator: Shapiro Haim, MD            
Sub-Investigator: Ronit Anbar, RD            
Sub-Investigator: Dana Pinsker, RD            
Sponsors and Collaborators
Rabin Medical Center
Israeli Ministry of Security
Investigators
Principal Investigator: Pierre Singer, MD, Professor Rabin Medical Center
  More Information

Publications:
Leaver SK, Evans TW. Acute respiratory distress syndrome. BMJ 335(7616):389-94, 2007
Gaynes RP, Horan TC. Surveillance of Nosocomial Infections.In: Mayhall CG, editor. Hospital Epidemiology and Infection Control. Philadelphia: Lippincott Williams & Wilkins,1285-1317,1999

Responsible Party: Pierre singer, Professor, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01099501     History of Changes
Other Study ID Numbers: PHMD- OT- 01
Study First Received: April 1, 2010
Last Updated: February 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Mechanical Ventilation

Additional relevant MeSH terms:
Craniocerebral Trauma
Multiple Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013