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

Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Decompensation in Liver Cirrhosis

• Study Type: Observational

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic liver disease patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver & Biliary Sciences, India.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cirrhotics with no previous decompensation
Cirrhotics with previous one or more than one decompensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spontaneous recovery or liver transplant or death in both groups	90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO