Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Propranolol and Midodrine: Drug: Propranolol
maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.
Drug: Midodrine
It w
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Decompensated Child C cirrhotics with grade II-III requiring primary prophylaxis
Exclusion criteria
Exclusion criteria: 1) Spontaneous bacterial peritonitis 2) Hepatic Encephalopathy 3) Acute renal failure (S.Cr >1.5) 4) Hepatorenal syndrome 5) Hypertension 6) Coronary Artery Disease ; H/o arrhythmias, heart block 7) Urinary retention 8) Pheochromocytoma/thyrotoxicosis 9) Coronary Obstructive Pulmonary Disease 10) Hepatocellular Carcinoma 11) Pregnancy 12) Portal vein Thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary prevention of first variceal bleedTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Ability to introduce diuretics, dose in both groups Timepoint: 1 year;Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baselineTimepoint: Day 7;Adverse effects of drugs in both groups • Impact on portal, systemic and cardiac hemodynamicsTimepoint: 1 year;HVPG reduction in both groupsTimepoint: Day 90;Impact on portal, systemic and cardiac hemodynamics in both groupsTimepoint: 1 year;Incidence of decrease in ascites by at least one grade in both groupsTimepoint: 3 months;Incidence of Hyponatremia,episodes of bacterial infection,Hepatic Encephalopathy,Hepato-Renal Syndrome,Acute Kidney Injury,Variceal Bleed in both groupsTimepoint: 1 year;Incidence of therapeutic paracentesis in both groupsTimepoint: day 90;Paracentesis induced circulatory dysfunction(PICD) in both groupsTimepoint: 1 year;Partial and complete resolution of ascites in both groups Timepoint: 3 and 6 months;Survival in both groups in both groupsTimepoint: day 180 and 360;TIPS (TransIntrahepatic Portosystemic Shunt) in both groupsTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Abhijeet Ranjan
Institute of Liver and Biliary Sciences
Outcome results
None listed