Oxepa in Multiple Trauma - Full Text View

Sponsor:	Rabin Medical Center
Collaborator:	Israeli Ministry of Security
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT01099501

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:

MedlinePlus related topics: Head Injuries Injuries Traumatic Brain Injury Wounds

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 2012
Estimated Primary Completion Date:	May 2012 (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.

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:

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

Exclusion criteria:

Severe underlying systemic disease and /or treatment with immunosuppressive agents.
Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
2nd /3rd degree burns covering > 66% BSA.
Pregnancy.
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:

Giannoudis PV. Current concepts of the inflammatory response after major trauma: an update. Injury. 2003 Jun;34(6):397-404. Review.

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

MacCallum NS, Evans TW. Epidemiology of acute lung injury. Curr Opin Crit Care. 2005 Feb;11(1):43-9. Review.

Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. Review.

Moore FA, Moore EE, Jones TN, McCroskey BL, Peterson VM. TEN versus TPN following major abdominal trauma--reduced septic morbidity. J Trauma. 1989 Jul;29(7):916-22; discussion 922-3.

Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3.

Kudsk KA, Minard G, Croce MA, Brown RO, Lowrey TS, Pritchard FE, Dickerson RN, Fabian TC. A randomized trial of isonitrogenous enteral diets after severe trauma. An immune-enhancing diet reduces septic complications. Ann Surg. 1996 Oct;224(4):531-40; discussion 540-3.

Moore FA, Moore EE, Kudsk KA, Brown RO, Bower RH, Koruda MJ, Baker CC, Barbul A. Clinical benefits of an immune-enhancing diet for early postinjury enteral feeding. J Trauma. 1994 Oct;37(4):607-15.

Todd SR, Gonzalez EA, Turner K, Kozar RA. Update on postinjury nutrition. Curr Opin Crit Care. 2008 Dec;14(6):690-5. Review.

Singer P, Theilla M, Fisher H, Gibstein L, Grozovski E, Cohen J. Benefit of an enteral diet enriched with eicosapentaenoic acid and gamma-linolenic acid in ventilated patients with acute lung injury. Crit Care Med. 2006 Apr;34(4):1033-8. Erratum in: Crit Care Med. 2006 Jun;34(6):1861.

Green P, Hermesh H, Monselise A, Marom S, Presburger G, Weizman A. Red cell membrane omega-3 fatty acids are decreased in nondepressed patients with social anxiety disorder. Eur Neuropsychopharmacol. 2006 Feb;16(2):107-13. Epub 2005 Oct 21.

Responsible Party:	Prof . P . Singer, MD, Rabin Medical Center/Clalit
ClinicalTrials.gov Identifier:	NCT01099501 History of Changes
Other Study ID Numbers:	PHMD- OT- 01
Study First Received:	April 1, 2010
Last Updated:	October 3, 2010
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 24, 2012