To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months.

Study Overview

• Status: Withdrawn
• Conditions: 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Cirrhosis: based on previous liver biopsy if available or based on clinical, imaging.

2. Severe acute hepatitis [14]: fulfilling any 2 of the 3 criteria:

   • Hepatic encephalopathy,
   • Serum bilirubin equal to or more than 10 mg/dl
   • International normalized ratio (INR) more than or equal to 1.6
3. Acute on chronic liver failure [3]: Acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5mg/dL) and coagulopathy (INR ≥ 1.5), complicated within 4 weeks by ascites and/or encephalopathy in patients with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.
4. Acute deterioration of decompensated cirrhosis [4]: Acute decompensation of cirrhosis in the form of one or more major complications of liver disease, including ascites, hepatic encephalopathy, gastrointestinal bleeding.

Description

Inclusion Criteria:

• All consecutive patients presenting to hospital with bilirubin ≥5 and INR≥1.5
• Cirrhosis with or without Decompensation presenting with acute deterioration in less than 3 month

Exclusion Criteria:

• Cirrhosis with chronic decompensation.
• Patient on anticoagulant
• Hepatocellular carcinoma
• Septic shock
• Post-liver transplant or resection

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Severe acute hepatitis; Severe acute hepatitis without ascites.
Non-cirrhotic
Cirrhotic patients with ascites
decompensated cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	3 months
Survival	3 months
total number of patients underwent Transplantation	3 months
Number of patients develop liver failure.	3 months
Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).	3 months
Number of patients develop sepsis.	3 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Fibrosis; Liver Failure; Acute-On-Chronic Liver Failure; Liver Cirrhosis; Ascites
• Other Study ID Numbers: ILBS-Cirrhosis-002