Track topics on Twitter Track topics that are important to you
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.
Improvement in oxygenation
Significant improvement in other clinical and laboratory end points.
Oxygenation (PO2- FIO2 ratio)
- Incidence of ALI
- Length of Ventilation (LOV)
Rate of complications:
-New organ failure.
Rate of new infections:
-wound infection, bacteremia, ventilation associated pneumonia.
-Pain score and analgesic use
- 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.
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.
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding., oxepa, Control group
Rabin Medical Center, Campus Beilinson
Not yet recruiting
Rabin Medical Center
Published on BioPortfolio: 2014-08-27T03:14:45-0400
The purpose of this prospective observational study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed populat...
This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.
The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemoth...
Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting. LTAC ...
Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be ...
The preferred method of nutrition support in the presence of a functional gastrointestinal tract is enteral nutrition (EN). Many factors contribute to the selection process for the type of enteral acc...
The effects of a high-protein, high-calorie, fiber- and fructo-oligosaccharide-enriched enteral formula on nutritional status, bowel habits and tolerance: Safety and Effectiveness of Enteral Nutrition in elderly Spanish patients (SENS Study).
Enteral nutrition (EN) is an effective nutritional intervention for patients at risk of malnutrition or malnourished. However, complications such as gastrointestinal intolerance, hyperglycemia or refe...
Early enteral nutrition is recommended in critically ill adult patients. The optimal method of administering enteral nutrition remains unknown. Continuous enteral nutrition administration in criticall...
Early enteral nutrition (EEN) and the continuation of enteral nutrition (EN) are critical factors in burn patients, who typically have higher nutritional needs due to their post-injury hypercatabolic ...
Home enteral nutrition (HEN) is an essential component in the care of patients with an array of underlying etiologies resulting in the inability to meet caloric needs through volitional intake alone. ...
The administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered by a route other than the alimentary canal (e.g., intravenously, subcutaneously).
The at-home administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered via a route other than the alimentary canal (e.g., intravenously, subcutaneously).
Nutritional support given via the alimentary canal or any route connected to the gastrointestinal system (i.e., the enteral route). This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, and jejunostomy tubes.
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Liquid formulations for the nutrition of INFANTS, useful for those with special needs or MILK HYPERSENSITIVITY or those whose mothers are unable to breastfeed (BREAST FEEDING).
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza, Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...