Oxepa in Multiple Trauma (OMT)

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Head Trauma; Multiple Trauma

Treatments: Dietary Supplement: Control group; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT01099501

PHMD- OT- 01

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Oxepa

Active Comparator group

Description:

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

Treatment:

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

Control group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control group