Patients in whom the necessity is foreseen to receive metabolic total parenteral nutrition like nutritional support, during a minimum period of 7 days, because they can not to be fed by route enteral or oral or patients whom receive enteral nutrition and do not reach 75% of the calculated power requirements to the three days of initiate the enteral nutrition.
Conditions
Interventions
Trade Name: Lipofundina MCT/LCT 20%
Product Name: NTP B with emulsions based on MCT/LCT to 20%
Pharmaceutical Form: Intravenous infusion
Product Name: Lipidic emulsion based on LCT to 20%
Pharmaceut
Sponsors
Metabolism and Nutrition Group of the SEMICYUC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes, entered of prospectiv form in the Intensive Medicin Units , older of 18 years, in which the necessity is foreseen to receive metabolic total parenteral nutrition like nutritional support, during a minimum period of 7 days. The indications to receive parenteral nutrition will be recommended by the American Society of Parenteral and Enteral Nutrition (REEL), and in particular: Severe Undernourishment. Intraabdominal main surgery Peritonitis Intestinal ischemia Intestinal occlusion Gastrointestinal Fistulas Short intestine Patients of both sexes, older of 18 years, that initiating the nutricional support with enteral diets in the first 3 days of entrance in the ICU, require parenteral nutrition by: Not to reach 75% of the power requirements calculated after three days of entrance receiving enteral nutrition To undergo intratables or persistent gastrointestinales complications of the enteral nutrition in the first 3 days from entrance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: APACHE II 39) Defined hepat disease like one of the following clinical patterns: Portal hypertension with gastrointestinal bled at the moment of the entrance Clinically apparent Ascitis of hepatocelular origin Bilirrubina higher to 3 mg/dL of hepatocelular origin Serum albumen smaller 30 of g/l with portal hypertension Encephalopathy degree II or higher Clinical diagnosis of alcoholic hepatitis. Chronic renal insufficiency defined by one of the following criteria: Plasma Creatinin greater 4 of mg/dL Chronic peritoneal dialysis or hemodialysis Patient with severe acquired hiperlipidemia or familiar of any type Serious chronic neurological disease defined by one of the following criteria: Cerebrovascular accident with persistent neurological deficit in the last six months Neurological deficit that forces the chronic confinement Neoplasic patients with metástasis and a smaller life expectancy of six months Patients under chemotherapy or x-ray or treatment with corticoids during the month previous to the study Treatment in continuous infusion for more than 24 hours with propofol or other drugs that use lipidic emulsions like vehicle Infectious Diseases transmitted by the blood, products derived from the blood or urine: hepatitis B, C and HIV To be including in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of nosocomial infection associated to the administration of two types of different lipidic emulsions, in the total parenteral nutrition of patients entered in a Service of Intensive Medicine;Secondary Objective: Study of mortality to the hospitable discharge and until the 3 months after the discharge;Primary end point(s): The primary variable of effectiveness is the density of incidence of nosocomial infections, expressed in number of episodes per 100 days of stay in ICU, except for pneumonia associated to mechanical ventilation (number of episodes per 100 days of mechanical ventilation) and of sepsis by catheter (number of episodes per 100 days of catheter) in the first 28 days of entrance in ICU, according to the methodology of the National Study of Nosocomial Infection in Services of Intensive Medicine ENVIN-UCI. The diagnosis of nosocomial infection will settle down according to the criteria of the CDC, with the exception of the sepsis by catheter that will be done following the Conference of Consensus of the SEMICYUC. | — |
Countries
Spain
Outcome results
None listed