Clinical Trial: Oxepa in Multiple Trauma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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 h
Sponsor: Rabin Medical Center

Current Primary Outcome: Oxygenation (PO2/FIO2 ratio) [ Time Frame: 2 years ]

PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • TNF-α, CRP (markers of inflammatory response) [ Time Frame: 2 years ]
    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 ]
    Fatty acid composition of RBC membrane (thin liquid chromatography)


Original Secondary Outcome: Same as current

Information By: Rabin Medical Center

Dates:
Date Received: April 1, 2010
Date Started: April 2010
Date Completion: August 2014
Last Updated: November 21, 2013
Last Verified: October 2013