Clinical trial NCT01099501: Oxepa in Multiple Trauma
Official title: Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multiple Trauma
Head Trauma
Keywords: Mechanical Ventilation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Israeli Ministry of Security
First posted: 2010-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygenation (PO2/FIO2 ratio)
timeFrame: 2 years
Secondary outcomes:
measure: TNF-α, CRP (markers of inflammatory response)
timeFrame: 2 years
measure: Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)
timeFrame: 2 years
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Campus Beilinson
Study officials:
affiliation: Rabin Medical Center
name: Pierre Singer, MD, Professor
role: PRINCIPAL_INVESTIGATOR
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