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.

Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02465619
• Other study ID #: ILBS-Cirrhosis-002
• Status: Withdrawn
• Phase: N/A
• First received: June 4, 2015
• Last updated: November 25, 2017
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Ascites
• Cirrhosis
• End Stage Liver Disease
• Fibrosis
• Liver Cirrhosis
• Liver Failure

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		28 days
Secondary	Survival		3 months
Secondary	total number of patients underwent Transplantation		3 months
Secondary	Mortality		3 months
Secondary	Number of patients develop liver failure.		3 months
Secondary	Number of patients develop SIRS (Systemic Inflammatory Response Syndrome).		3 months
Secondary	Number of patients develop sepsis.		3 months