Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation

Withdrawn

• Conditions: Acute Decompensation in Liver Cirrhosis

• Registration Number: NCT03005587
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2016-12-31
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
2. Age 18-70 years
3. Valid consent

Exclusion Criteria

1. HepatoCellular Carcinoma
2. Admitted and survival less than 48 hrs
3. Pregnant
4. Acute Liver Failure
5. Post transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spontaneous recovery or liver transplant or death in both groups	90 days

Secondary Outcome Measures

Name	Time	Method
Causes of death in both groups	3 months
Sepsis in both groups	3 months
Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups	3 months
Improvement in severity assessment Indices CLIF score in both groups	3 months
Cause of acute decompensation	3 months
Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.	3 months
Improvement in severity assessment Indices Child Pugh Turcotte in both groups.	3 months
Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups	3 months
Systemic Inflammatory Response Syndrome in both groups	3 months
Severity and duration of prior as well as present decompensation	3 months
Profile of patient undergone transplant in both groups	3 months

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences.; 🇮🇳 New Delhi, Delhi, India