Clinical trial NCT02465619: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 28 days
Secondary outcomes:
measure: Survival
timeFrame: 3 months
measure: total number of patients underwent Transplantation
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
measure: Number of patients develop liver failure.
timeFrame: 3 months
measure: Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).
timeFrame: 3 months
measure: Number of patients develop sepsis.
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: