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IRCT20190619043942N1 IRCT 2021-12-09 Shiraz University of Medical Sciences Impact of Octreotide on Renal Function of Patients after Liver Transplantation Impact of Octreotide on Renal Function of Patients after Liver Transplantation; A Randomized, Double-Blind, Placebo-Controlled Trial 2021-07-23 anticipated 60 Complete https://irct.ir/trial/40316 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomized into two groups at a ratio of 1:1 using random allocation software (RAS)(M. 2004). The randomization codes remained concealed until all patients had completed their follow-up and the database had been verified and closed. There is no emergency case that required breaking the blind on randomization, Blinding description: Allocation concealment:Numbered drug containers, Blinding description: This study is double blind. Researcher and clinical care giver who complete questionnaire and patients are blind. 4 Liver Transplantation. Intervention 1: intervention group 1: octerotide 50 mg / h intravenous infusion for three days from one of the Domestic manufacturer factory that will be provided by Namazi Hospital Intervention. Intervention 2: Control group: Placebo 50 mg / h intravenous infusion for three days from one of the domestic manufacturer factory, the same as octerotide. Yes - There is a plan to make this available What will be shared: The file contains the results analysis When: Six months after the completion of the project To whom: ethics committee With the permission of the researchers Conditions: In accordance with the informed consent form and the proposal approved Use of information can only be done anonymously For the purpose of verifying and approving the original proposal Only researchers related to this project will have access to information If approved by the Research Vice-President of the University and the Ethics Committee: The use of other people for other research purposes will be possible. Where to obtain: responsible person of project email Dr. Kamran Bagheri Lankarani How to obtain: Ask official request from the Deputy of Research and Technology(SUMS). Comments:
public kamran bagheri lankarani
zand street
shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3230 9615 lankaran@sums.ac.ir Shiraz University of Medical Sciences scientific kamran bagheri lankarani
zand street
shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3230 9615 lankaran@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 1.Age between 18 and 60 years 2.Cirrhosis of the liver defined by clinical, biochemical or histological That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose 18 years 80 years Both 1.Pregnant women, nursing mothers, or those who intend to become pregnant during the study period 2.Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg 3.Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts 4.Simultaneous Liver, Kidney Transplant 5.Cardiac or respiratory failure 6.Positive for human immunodeficiency virus 7.Urinary retention 8.Ischemic heart disease or peripheral vascular disease 9.Narrow Angle Glaucoma 10.Cerebrovascular occlusions 11.Aortic Aneurysm 12.Thyrotoxicosis 13.Pheochromocytoma 14.Diabetes Melitus 15.History of Hemodialysis prior to Liver Transplant 16.PreTransplant Cr more than 2.5mg/dl Z94.4 Liver transplant status Treatment - Drugs Placebo intervention group 1: octerotide 50 mg / h intravenous infusion for three days from one of the Domestic manufacturer factory that will be provided by Namazi Hospital Intervention Control group: Placebo 50 mg / h intravenous infusion for three days from one of the domestic manufacturer factory, the same as octerotide 1. Glomerular filtration. Timepoint: 3 Days after Intervention, 1week after Intervention, 4 weeks after Intervention. Method of measurement: Change in glomerular filtration rate measured by isotopic tests. Changes in renal function. Timepoint: 3days, 1 week, 4 weeks after cessation of treatment. Method of measurement: Lab test. Shiraz University of Medical Sciences Approved 2021-08-10 Ethics Committee of Shiraz University of Medical Sciences. zand street shiraz Fars Iran (Islamic Republic of)