Health Condition 1: K721- Chronic hepatic failure
Conditions
Interventions
Intervention1: Carvedilol: Carvedilol will be started at 3.125 - 6.25 mg per day and up- titrated to a maximum of 12.5 mg per day.
Control Intervention1: Propranolol: Propranolol will be started at a
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cirrhosis (of any etiology) as diagnosed on the basis of blood parameters, imaging or Fibro Scan 2. Source of UGIB is determined to be from esophageal varices and is successfully tackled using EVL. Variceal origin of UGIB will be considered based on endoscopic findings of: a. Ongoing bleed from esophageal varices b. Endoscopic stigmata of recent or high risk of bleed including red coloured streaks, blue hemocystic spot, cherry red sign and nipple sign c. No other source of bleed and presence of bandable varices 3. Patients with acute kidney injury (International Ascites Club criteria) or acute- on-chronic liver failure (as per the CANONIC definition) at presentation will be included in the study only if these have resolved by the time of randomization
Exclusion criteria
Exclusion criteria: 1. Patients who are already receiving NSBB at index presentation 2. Failure to control UGIB using EVL 3. Presence of gastric varices 4. Presence of hepatocellular carcinoma or other active malignancy 5. Presence of portal vein thrombosis 6. Patients with acute-on-chronic liver failure (as per the CANONIC definition) at the time of randomization 7. Patients with acute kidney injury (by International Ascites Club criteria) at the time of randomization 8. Patients with bradycardia, sick-sinus syndrome, heart-block or other significant ECG abnormalities 9. Systolic blood pressure less than 90 mm-Hg or mean arterial pressure less than 70 mm-Hg at the time of randomization 10. Patients with bronchial asthma, chronic obstructive airway disease, peripheral vascular disease, Raynauds phenomenon or other contraindications to the use of non selective beta blockers. 11. Patients with transjugular intrahepatic portosystemic shunt (TIPS) 12. Patients having Refractory Ascites 13. Pregnant patients 14. Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first variceal re-bleedTimepoint: within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Early variceal re-bleed within 6-weeks of index EVL (bleed from post-EVL ulceration will not be considered as variceal re-bleed)Timepoint: within 12 months;12-month transplant free survivalTimepoint: within 12 months;Change in mean arterial pressure (MAP)Timepoint: at 1month, 6 months and 12 months;Change in severity of portal hypertensive gastropathy (PHG). PHG will be graded as mild or severe depending on the absence or presence of central red spot. Timepoint: at 12 months or last endoscopy;New onset acute kidney injury (AKI)Timepoint: within 12-months;New onset Hepatic EncephalopathyTimepoint: within 12 months;New onset Spontaneous Bacterial Peritonitis, other infectionsTimepoint: within 12 months;Ascites controlTimepoint: at 6 and 12-months;Adverse eventsTimepoint: within 12 months | — |
Countries
India
Contacts
Public ContactVishavdeep Singh Rana
Postgraduate Institute of Medical Education and Research
Outcome results
None listed