Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease. A Randomized Controlled Trial.

Institute of Liver and Biliary Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Age > 18 years <70years
•2.Patient with NAFLD associated cirrhosis and moderate ascites
•3.Stable eGFR-( more than 60 ml per min per 1.73m2) calculated using MDRD-6 equation:
•4.Valid Informed written consent

•1.Hospitalized patients
•2.CTP-C patients
•3.Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
•4.History of organ transplantation
•5.Refractory Ascites
•6.Type 1 DM
•7.History of hypoglycemic symptoms in the last 2 months
•8.Recurrent UTI
•9.Patient with HCC or portal vein thrombosis
•10.Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
•11.History of fracture in the preceding year
•12.Severe Hyponatremia (Na <125 MEq/L)
•13.Pregnancy or Lactating mother
•14.Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
•15.MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
•16.Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
•17.Mixed ascites (additional etiology of ascites apart from portal hypertension)
•18.Any severe extra hepatic condition including respiratory and cardiac failure
•19.Acute-on-chronic liver failure as per the APASL criteria
•20.Refusal to give consent

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