Oxepa in Multiple Trauma (OMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: November 21, 2013
Last verified: October 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Singer P, Cohen J: Indirect calorimetry and metabolic monitoring. In Fink M, Abraham E (eds), Textbook of Critical Care, Springer eds (Berlin), 2005 pp.]
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: November 21, 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 August 28, 2014