To see the effect of vasoactive drugs on control of variceal bleeding in participants with liver cirrhosis

Not Applicable

Not yet recruiting

Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Registration Number: CTRI/2024/05/066720

Lead Sponsor: All India Institute Of Medical Sciences, New Delhi, Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Cirrhosis (Child A and Child B; CTP score =9) with acute esophageal variceal bleeding for whom adequate endotherapy has been performed

2. Age between 18-65 years

3. Willing to participate in the study

Exclusion Criteria

1.Patients already included in the trial presenting with repeat variceal bleeding

2.Failure to achieve primary hemostasis

3.Bleeding from cardiofundal varices

4.Portosinusoidal vascular disorders, and splanchnic vein thrombosis

5.Patients who have Child C cirrhosis

6.History of prior TIPS or TIPS thrombosis

7.HVOTO

8.Acute-on-chronic liver failure as per the European Association for the Study of Liver definition

9. Overt Hepatic encephalopathy

10.Patients with any co-existent malignancy including HCC

11.Patients with bleeding diathesis.

12.Pregnant women

13.Patients with renal dysfunction serum creatinine greater than 2 mg per dL

14.Patients with sepsis, shock or requiring mechanical ventilation

15.Contraindications to NSBBs including prior documented hypersensitivity, unacceptable adverse events including hypotension or dizziness and cardiac comorbidities such as heart block

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysisTimepoint: 1.Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis

Secondary Outcome Measures

Name	Time	Method
1.5-day rebleeding rates with mortality and transplant as competing events <br/ ><br>2.6-week all-cause decompensation, with mortality as additional competing event <br/ ><br>3.6-week transplant-free survival <br/ ><br>4.Need for rescue therapy, such as rescue TIPS, Dannis-Ella shunt, Balloon tamponade. <br/ ><br>5.Drug-related adverse effects <br/ ><br>6.Duration of hospital stay for index bleed <br/ ><br>7.Cumulative 6-week rebleeding rates with death and transplant as competing events <br/ ><br>8.Cost-effectiveness analysis (see details below) <br/ ><br>Timepoint: At 6 weeks