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 ]
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