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.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03005587

Enrollment

Registered

2016-12-29

Start date

2016-12-31

Completion date

2017-03-01

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensation in Liver Cirrhosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Cause of acute decompensation	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
Systemic Inflammatory Response Syndrome in both groups	3 months

Countries

India

Outcome results