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Completed

NCT Number: NCT02583698

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

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.

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Key information

Conditions

Acute on Chronic Liver Failure Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Carvedilol

Drug

Placebo

Drug

Primary outcomes

  1. Mortality in both groups

    Time frame: 28 days

Secondary outcomes

  1. Number of patients with development or progression of esophageal varices in both groups.

    Time frame: 3 Months

  2. Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.

    Time frame: 3 Months

  3. Number of patients with regression in esophageal varices in both groups.

    Time frame: 3 Months

  4. Number of patients with improvement in Liver severity scores in both groups.

    Time frame: 28 days

  5. Number of patients with improvement in Liver severity scores in both groups.

    Time frame: 60 days

  6. Number of patients with improvement in Liver severity scores in both groups.

    Time frame: 3 months

  7. Number of patients with development of adverse events in both groups in both groups.

    Time frame: 28 days

  8. Number of patients with development of adverse events in both groups in both groups.

    Time frame: 2 months

  9. Number of patients with development of adverse events in both groups in both groups.

    Time frame: 3 Months

  10. Number of patients who will develop esophageal variceal bleeding in both groups

    Time frame: 28 days

  11. Number of patients who will develop esophageal variceal bleeding in both groups

    Time frame: 2 Months

  12. Number of patients who will develop esophageal variceal bleeding in both groups

    Time frame: 3 Months

  13. Development of complications in both groups

    Time frame: 28 days

    AKI,Pneumonia,SBP and other infections

  14. Development of complications in both groups

    Time frame: 2 months

    AKI,Pneumonia,SBP and other infections

  15. Development of complications in both groups

    Time frame: 3 months

    AKI,Pneumonia,SBP and other infections

  16. Mortality in both groups

    Time frame: 2 months

  17. Mortality in both groups

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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