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.

NCT02465619 | Withdrawn

• 1 other identifier: ILBS-Cirrhosis-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Survival

  28 days

Secondary Outcomes (6)

• Survival

  3 months

• total number of patients underwent Transplantation

  3 months

• Mortality

  3 months

• Number of patients develop liver failure.

  3 months

• Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).

  3 months

Study Arms (4)

Severe acute hepatitis

Severe acute hepatitis without ascites.

Non-cirrhotic

Cirrhotic patients with ascites

decompensated cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 8, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-01

Locations

IN (1)