Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS. Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be titrated every 2ndday to attain a target heart rate of 55. One group patients will be given maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.The patients who bleed will undergo EVL session. To the other group Midodine will be added to Propranolol.It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate. The patients who bleed will undergo EVL session. Monitoring and assessment : The patient will be monitored every day. The patient will undergo physical examination, complete blood counts, at baseline, LFT, KFT, at every 2nd day and day 7 from the start of therapy. Adverse effects : Bradycardia and hypotension due to beta blockers Stopping rule : Severe hyponatraemia (\<125), low mean arterial pressure(\<65) or cardiac output and increasing serum creatinine(\>1.5) identifies more vulnerable patients among those with decompensated cirrhosis, in whom a dose reduction or temporal discontinuation of NSBB treatment will be considered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.
It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Primary prevention of first variceal bleed in both groups
prevention of first variceal bleed is based on clinicallly
Time frame: 1 year
Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baseline
Time frame: Day 7
HVPG reduction in both groups
HVPG reduction by 20% from baseline
Time frame: Day 90
Survival in both groups
Time frame: 1 year
Incidence of therapeutic paracentesis in both groups
Time frame: Day 30
Incidence of therapeutic paracentesis in both groups
Time frame: Day 90
Incidence of decrease in ascites by at least one grade in both groups
Time frame: 3 months
Paracentesis induced circulatory dysfunction(PICD) in both groups
PICD is defined as Incidence of AKI and HE after paracentesis
Time frame: 1 year
Incidence of Hyponatremia in both groups
cut off for Hyponatremia is Sodium \< 135
Time frame: 1 year
Episodes of bacterial infection in both groups
Bacterial infection will be identified by culture tests
Time frame: 1 year
Incidence of Hepatic Encephalopathy in both groups
Time frame: 1 year
Incidence of Hepato Renal Syndrome in both groups
Time frame: 1 year
Incidence of Acute Kidney Injury in both groups
Time frame: 1 year
Incidence of Variceal bleed in both groups
Time frame: 1 year
Number of TIPS (TransIntrahepatic Portosystemic Shunt) procedure done in both groups
Time frame: 1 year
Number of patients who will receive diuretics in both groups
Time frame: 1 year
Adverse effects of drugs in both groups
Time frame: 1 year
Impact on portal, systemic and cardiac hemodynamics in both groups
For Portal and cardiac HVPG and right heart pressure studies will be done and for systemic blood pressure will be measured
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.