A randomised double blind controlled crossover trial of intravenous taurine supplementation in parenteral nutrition as an effective treatment for reducing hepatobiliary complications in chronic intestinal failure. - taurine in HP

orth west London Hospital Trust0 个研究点目标入组 24 人开始时间: 2005年6月2日最近更新: 2020年7月27日

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•All patients over the age of 18 years on long term home parenteral nutrition under the care of the Nutrition and Intestinal Failure clinic at St Mark’s Hospital who have PNAC. Patients with intestinal failure on HPN rarely have liver biopsies as the results do not alter the patient’s management. A surrogate definition in the literature is based on persistently abnormal liver function tests (LFT’s). Chronic cholestasis has been defined as occurring when two of the three LFT’s are persistently elevated for over 6 months to a value of 1.5-fold the upper limit of normal (?- glutamyl-transferase, alkaline phosphatase, and serum conjugated bilirubin) (Nanji 1985). Patients would be expected to have a life expectancy of over 6 months and have been stable on HPN for 6 months before entry into the trial. HPN should provide >75-80% of their estimated nutritional requirements and patients should be on HPN for 5 days or more per week.
•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

•No consent, pregnancy/lactation, planned surgery, renal failure, hepatic failure (prothrombin time twice the upper limit), ultrasound proven fibrosis or cirrhosis, poorly controlled diabetes, hepatitis B or C, autoimmune liver disease, receiving >40kcal/kg/day from HPN, current sepsis, co-existing surgical complications such as intestinal obstruction, hepatotoxic drugs, primary liver cancer or liver metastases or any other cause for pre and post hepatic jaundice, inability to adhere to the trial protocol or participation in another intervention trial.

发起方

orth west London Hospital Trust