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 infection

Metabolism and Nutrition Group of the SEMICYUC0 个研究点目标入组 240 人开始时间: 2004年12月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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.

发起方

Metabolism and Nutrition Group of the SEMICYUC