FindTrial
Sign In

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

Comparison of no vasoactive agent with 1-day vasoactive agent after endoscopic variceal ligation in patients with cirrhosis presenting with acute variceal bleeding: an open-label non-inferiority trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066720
Enrollment
494
Registered
2024-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: No vasoactive agent after endoscopic hemostasis: Somatostatin will be stopped in intervention group once endoscopic hemostasis has been achieved. Control Intervention1: 1 day Somatostat

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis (Child A,Child B and Child C) 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

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. History of prior TIPS or TIPS thrombosis 6. HVOTO 7. Acute-on-chronic liver failure as per the European Association for the Study of Liver definition 8. Overt Hepatic encephalopathy 9. Patients with any co-existent malignancy including HCC 10. Patients with bleeding diathesis. 11. Pregnant women 12. Patients with renal dysfunction serum creatinine greater than 2 mg per dL 13. Patients with sepsis, shock or requiring mechanical ventilation 14. Contraindications to NSBBs including prior documented hypersensitivity, unacceptable adverse events including hypotension or dizziness and cardiac comorbidities such as heart block

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. 5-day rebleeding rates with mortality and transplant as competing events 2. 6-week all-cause decompensation, with mortality as additional competing event 3. 6-week transplant-free survival 4. Need for rescue therapy, such as rescue TIPS, Dannis-Ella shunt, Balloon tamponade. 5. Drug-related adverse effects 6. Duration of hospital stay for index bleed 7. Cumulative 6-week rebleeding rates with death and transplant as competing events 8. Cost-effectiveness analysis (see details below) Timepoint: At 6 weeks—

Countries

India

Contacts

Public ContactGovindaraju Chukkala

AIIMS, New Delhi

liverclinicaiims@gmail.com9810038116

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026