Oxepa in Multiple Trauma

Study Overview
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Brief Summary
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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 Description
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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

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

Conditions
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Multiple Trauma, Head Trauma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxepa<br>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.<br>* Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding<br>Dietary Supplement: oxepa<br>* A dose determined by a patient's energy expenditure and tolerance of enteral feeding.<br>|
| Active Comparator: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation (PO2/FIO2 ratio) | PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-α, CRP (markers of inflammatory response) | Concentration of circulating inflammatory markers: TNF-α, CRP concentrations | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Ventilation