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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583698
Other study ID # ILBS-ACLF-005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date July 1, 2017

Study information

Verified date November 2017
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Carvedilol

Placebo


Locations

Country Name City State
India Institute of liver and Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality in both groups 28 days
Secondary Number of patients with development or progression of esophageal varices in both groups. 3 Months
Secondary Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups. 3 Months
Secondary Number of patients with regression in esophageal varices in both groups. 3 Months
Secondary Number of patients with improvement in Liver severity scores in both groups. 28 days
Secondary Number of patients with improvement in Liver severity scores in both groups. 60 days
Secondary Number of patients with improvement in Liver severity scores in both groups. 3 months
Secondary Number of patients with development of adverse events in both groups in both groups. 28 days
Secondary Number of patients with development of adverse events in both groups in both groups. 2 months
Secondary Number of patients with development of adverse events in both groups in both groups. 3 Months
Secondary Number of patients who will develop esophageal variceal bleeding in both groups 28 days
Secondary Number of patients who will develop esophageal variceal bleeding in both groups 2 Months
Secondary Number of patients who will develop esophageal variceal bleeding in both groups 3 Months
Secondary Development of complications in both groups AKI,Pneumonia,SBP and other infections 28 days
Secondary Development of complications in both groups AKI,Pneumonia,SBP and other infections 2 months
Secondary Development of complications in both groups AKI,Pneumonia,SBP and other infections 3 months
Secondary Mortality in both groups 2 months
Secondary Mortality in both groups 3 months
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