Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Carvedilol: Arm A will receive carvedilol plus standard medical therpy,Carvedilol: will be started with initial dose of 3.125 mg BD then After 3 days, increase the dose to 6.25 mg BD, M
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-65 years Liver cirrhosis Grade II-III high SAAG ascites Small low risk or no esophageal varices CTP 7-12
Exclusion criteria
Exclusion criteria: Age AKI at enrollement (Prior transient volume responsive AKI stage I included) Post renal or liver transplantation History of CAD, PVD, ventricular arrythmia, Bronchial asthma SBP at diagnosis Severe Hyponatremia (Na Grade II/III/IV HE Advanced HCC (BCLC C,D), PVTT, Pregnancy or Lactating mother High risk varices (Large varices or small high risk varices) CTP >12 ACLF Mixed / TB ascites Bilirubin >5 mg/dl Known CKD, obstructive uropathy Patient on MV, NIV, systemic sepsis and shock Lack of informed consent Prior intolerance or S/E to carvedilol or diuretics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of development of complicated ascites (any of refractory ascites, AKI-HRS, SBP, severe hyponatremia)Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Ascites resolutionTimepoint: 3m, 6m and 1 year;â?¢ Change in grade of varices and HVPGTimepoint: 1 year;â?¢ Change in MELD, CTP scoreTimepoint: 3m, 6m and 1 year;â?¢ Incidence of HE, variceal bleed, AKI, SBP, severe hyponatremia and refractory ascitesTimepoint: 6 month and 1 year;â?¢ Maximum tolerated dose of carvedilolTimepoint: 1 year;â?¢ Need and frequency of LVP and incidence of PICDTimepoint: 1 year;â?¢ Treatment (Carvedilol) related adverse effects and their gradesTimepoint: 1 year;MortalityTimepoint: 1 YEAR | — |
Countries
India
Contacts
Public ContactDr Ankur Jindal
Institute of Liver and Biliary Sciences
Outcome results
None listed