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IRCT20100111003043N12 IRCT 2018-07-16 Tehran University of Medical Sciences "Effect of L-Carnitine on transplanted liver function" Evaluation of the effects of L-carnitine on liver function after liver transplantation 2018-06-28 anticipated 80 Complete https://irct.ir/trial/31258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomized to L-Carnitine or placebo group by block randomization in sealed envelops. Allocation will be concealed up to the end of data analysis, Blinding description: L-Carnitine and placebo will be provided the same in shape and package. Patients, their physicians and nurses and statistician are blinded to the patients group; however, main investigator who assess the trial's outcome is not blinded. 2-3 Liver transplantation. Intervention 1: L-Carnitine syrup 500 mg per 5 cc, 500 mg twice a day from the time of entry to the transplant waiting list up to the day of liver transplantation will be used. Intervention 2: Placebo syrup, 5 cc twice a day from the time of entry to the transplant waiting list up to the day of liver transplantation will be used. Yes - There is a plan to make this available What will be shared: Data related to main outcomes of the study will be shared of deidentified IPD as SPSS file. When: Data will become available three months after publishing the related article. Data will be available for one year. To whom: Data will be available for people working in academic institution. Conditions: An agreement deal between Liver Transplantation research Center of Tehran University of Medical Sciences and people/institution who want to have access to data is needed. Where to obtain: The applicant should contact with Professor Simin Dashti-Khavidaki to get these documents or data files. The contact details of Simin Dashti-Khavidaki is: E-mail: dashtis@sina.tums.ac.ir Tel/FAx: 0098 21 66954709 How to obtain: Applicant request will be assessed in the meeting of Liver Transplantation Research Center of Tehran University of Medical Sciences and data will be provided for him/her within 2 months after application acceptance and agreement deal signing. Comments:
public Behrooz Khajeh
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar St., Enqelab Sq.
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6695 4709 b_khajeh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Simin Dashti-Khavidaki
Faculty of Pharmacy, 16Azar St., Enqelab Sq.,
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6695 4709 dashtis@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All patients over 14 years old with liver cirrhosis who are candidate for the first liver transplantation on the liver transplant list of Imam Khomeini Hospital Complex Patient's consent to enter the study 14 years 70 years Both Children under the age of 14 years who are candidate for liver transplantation Patients candidate for liver re-transplantation Patients who are candidate for liver transplant due to acute liver failure Patients undergoing simultaneous multiple organ transplantations (simultaneous liver-kidney transplantation, simultaneous liver-pancreas-kidney transplantation) Patients undergoing split liver transplantation from living donors or deceased donors Pregnant or lactating women History of allergy to L-Carnitine Patients with a history of seizure Patients with postoperative unstable conditions such as fever, sepsis, and shock, Cardiac instability (ACS/MI), gastrointestinal bleeding, long-term need for vasopressor (norepinephrine at doses greater than 0.5 μg/kg/min) T86 Complications of transplanted organs and tissue Treatment - Drugs Placebo L-Carnitine syrup 500 mg per 5 cc, 500 mg twice a day from the time of entry to the transplant waiting list up to the day of liver transplantation will be used. Placebo syrup, 5 cc twice a day from the time of entry to the transplant waiting list up to the day of liver transplantation will be used. Evaluation of the occurrence of primary graft non-function after liver transplantation. Timepoint: Daily within first week after liver transplantation. Method of measurement: Laboratory evaluation of liver function tests including international normalized ratio, serum aminotransferases, serum bilirubin, lactate concentration, blood glucose, venous or arterial blood pH. Evaluation of the occurrence of initial graft poor function after liver transplantation. Timepoint: Daily within first week after liver transplantation. Method of measurement: Laboratory evaluation of liver function tests including international normalized ratio, serum aminotransferases, serum bilirubin, lactate concentration, blood glucose, venous or arterial blood pH. Evaluation of occurrence of kidney function after liver transplantation. Timepoint: Daily within first week after liver transplantation. Method of measurement: Urinary output measurement and laboratory assessment of serum creatinine concentration. Evaluating length of ICU stay. Timepoint: Daily from ICU admission to ICU discharge. Method of measurement: Counting the days of ICU stay. Evaluating length of hospital stay. Timepoint: Daily from transplant surgery to hospital discharge. Method of measurement: Counting the days of hospital stay. Tehran University of Medical Sciences Approved 2018-06-10 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, 16 Azar st, Enghelab st, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)