Oxepa in Multiple Trauma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Trauma Head Trauma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mechanical Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxepa

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

Group Type ACTIVE_COMPARATOR