Acute Decompensation in Liver Cirrhosis Clinical Trial
Official title:
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.
| Verified date | June 2018 |
| Source | Institute of Liver and Biliary Sciences, India |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 1, 2017 |
| Est. primary completion date | March 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver and Biliary Sciences. | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Spontaneous recovery or liver transplant or death in both groups | 90 days | ||
| Secondary | Cause of acute decompensation | 3 months | ||
| Secondary | Severity and duration of prior as well as present decompensation | 3 months | ||
| Secondary | Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups. | 3 months | ||
| Secondary | Causes of death in both groups | 3 months | ||
| Secondary | Profile of patient undergone transplant in both groups | 3 months | ||
| Secondary | Sepsis in both groups | 3 months | ||
| Secondary | Systemic Inflammatory Response Syndrome in both groups | 3 months | ||
| Secondary | Improvement in severity assessment Indices Child Pugh Turcotte in both groups. | 3 months | ||
| Secondary | Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups | 3 months | ||
| Secondary | Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups | 3 months | ||
| Secondary | Improvement in severity assessment Indices CLIF score in both groups | 3 months |