Oxepa in Multiple Trauma

Multiple Trauma Clinical Trial

— OMT  

Official title:

Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01099501
• Other study ID #: PHMD- OT- 01
• Status: Recruiting
• Phase: Phase 4
• First received: April 1, 2010
• Last updated: November 21, 2013
• Start date: April 2010
• Est. completion date: August 2014

Study information

• Verified date: October 2013
• Source: Rabin Medical Center
• Contact: Pierre Singer, Principal Investigator MD
• Phone: 972-3-9376521
• Email: psinger[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Primary outcome:

Improvement in oxygenation

Secondary outcomes:

Significant improvement in other clinical and laboratory end points.

Primary endpoint:

Pulmonary function:

Oxygenation (PO2- FIO2 ratio)

• Incidence of ALI

• Length of Ventilation (LOV)

Secondary endpoints:

Rate of complications:

-New organ failure.

Rate of new infections:

-wound infection, bacteremia, ventilation associated pneumonia.

Pain:

-Pain score and analgesic use

Morbidity/ mortality:

• Length of ICU stay

• Length of hospitalization

• 28 day mortality

• Hospital mortality

All patients will commence enteral feeding via a nasogastric or orogastric tube; allocation to either Oxepa or Pulmocare/Jevity (control group) will be determined by randomization code. Patients will be prescribed to receive a daily amount of enteral formula that provides at least 80% of their energy; the latter will be calculated every 48 to 72 hours by Indirect Calorimetric (IC) measurement of Resting Energy Expenditure (REE). Tolerance of EN will be assessed by measurement of Gastric Residual Volume (GRV) every 8 hrs and the mode of feeding will be modified accordingly.

Treatment:

Enrolled patients will be randomly divided into a control group and an intervention group.

Control group treatment:

Will be administered Pulmocare or Jevity (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.

Intervention group treatment:

Will be administered with Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.

Treatment duration:

The above formulas will be/delivered until the first of the following occurs:

• patients resume regular oral feeding

• day 28/ discharge from ICU/ exitus

• Patients transferred to Total Parenteral Nutrition Note: the attending physician according to the patient's needs will determine feeding of patients from there on.

Study termination (end of all study procedures):

• day 28/ discharge from ICU

• Patients transferred to Total Parenteral Nutrition before day 3 of the study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Trauma
• Multiple Trauma
• Wounds and Injuries

Intervention

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
• oxepa
A dose determined by a patient's energy expenditure and tolerance of enteral feeding.
• 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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Campus Beilinson	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Israeli Ministry of Security

Country where clinical trial is conducted

Israel, 

References & Publications (13)

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. — View Citation

Gaynes RP, Horan TC. Surveillance of Nosocomial Infections.In: Mayhall CG, editor. Hospital Epidemiology and Infection Control. Philadelphia: Lippincott Williams & Wilkins,1285-1317,1999

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

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. — View Citation

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. — View Citation

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. — View Citation

Leaver SK, Evans TW. Acute respiratory distress syndrome. BMJ. 2007 Aug 25;335(7616):389-94. Review. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

Todd SR, Gonzalez EA, Turner K, Kozar RA. Update on postinjury nutrition. Curr Opin Crit Care. 2008 Dec;14(6):690-5. doi: 10.1097/MCC.0b013e3283196562. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation (PO2/FIO2 ratio)	PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)	2 years	No
Secondary	TNF-a, CRP (markers of inflammatory response)	Concentration of circulating inflammatory markers: TNF-a, CRP concentrations	2 years	No
Secondary	Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)	Fatty acid composition of RBC membrane (thin liquid chromatography)	2 years	No