Study prospective, multicenter, randomized, comparative, double blind, to evaluate two different lipidic emulsions in the total parenteral nutrition of the critic patient and their influence in the nocosomial infectio
- Conditions
- Patients in whom the necessity is foreseen to receive metabolictotal parenteral nutrition like nutritional support, during a minimumperiod of 7 days, because they can not to be fed by route enteral or oral orpatients whom receive enteral nutrition and do not reach 75% of thecalculated power requirements to the three days of initiate the enteral nutrition.
- Registration Number
- EUCTR2004-001299-38-ES
- Lead Sponsor
- Metabolism and Nutrition Group of the SEMICYUC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 240
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
APACHE II < 13
Morbid obesity (BMC> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method