Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute on Chronic Liver Failure

Treatments: Drug: Carvedilol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02583698

ILBS-ACLF-005

Details and patient eligibility

About

Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
2. 18-75 years
3. HVPG ≥ 12 + No/Small Esophageal varices

Exclusion criteria

1. Bradycardia (HR < 60/ min)
2. Hypotension
3. Asthma
4. LVF
5. AKI (Acute Kidney Injury), (S.creat >1.5)
6. Refractory ascites
7. SBP (Spontaneous Bacterial Peritonitis)
8. Pregnancy or Lactation
9. Past history of EVL or EST
10. Significant cardio - pulmonary co-morbidity
11. PVT
12. Presence of grades 3-4 hepatic encephalopathy (HE)
13. Patients going for liver transplant in next 12 weeks
14. No consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups, including a placebo group

Carvedilol

Experimental group

Description:

Tab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP \> 90 mmHg and HR \>55/min

Treatment:

Drug: Carvedilol

placebo

Placebo Comparator group

Treatment:

Drug: Placebo