Acute on Chronic Liver Failure Clinical Trial
Official title:
Prognostic Significance of Acute Change in Liver and Splenic Stiffness in Patients of Acute on Chronic Liver Failure
Acute-on-chronic liver failure (ACLF) is a syndrome associated with a high short- term mortality. Early identification of patients at high risk is important to determine emergency for transplantation and prioritize the need for intensive care unit. Unbalanced systemic inflammatory response is closely associated with mortality in ACLF patients. This systemic inflammatory response in ACLF increases liver and splenic stiffness stiffnes, which can be detected by transient elastography. Very few studies have been done in past evaluating liver and splenic stiffness as prognostic tool in patients of ACLF. These studies have taken only single value of liver and splenic stiffness as prognostic tool. No follow up study have yet been done assessing acute change in liver and splenic stiffness in ACLF. In this study, we hypothesize that acute change in liver and splenic stiffness at 7th & 14 th day predicts outcome in ACLF patients. With this study, we aim to evaluate whether acute changes in liver and splenic stiffness at 7th & 14th day predicts outcome at 3 months in patients of ACLF.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Patients of ACLF as per APASL criteria between 18 to 70 years of age 2. Patient and attendants willing to give informed consent Exclusion Criteria: 1. Age <18 years and > 70 years 2. Survival less than 7 days 3. Cirrhosis with prior decompensation 4. Grade 3 ascites 5. Hepatic encephalopathy grade III &IV 6. HCC/SOL >2cm in liver 7. Patient with congestive heart failure 8. Patient with extrahepatic cholestasis 9. Portal vein thrombosis 10. BMI >30 kg/m2 11. Prior variceal endotherapy or ongoing beta blocker treatment for varices 12. Pregnant and lactating women 13. Patient with cardiac pacemaker 14. Critically ill patients |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences | New Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute changes in liver and splenic stiffness on day 7 in patients of ACLF predicts liver transplant free survival at 3 months. | 3 months | ||
Secondary | Acute changes in liver and splenic stiffness on day 14 in patients of ACLF predicts liver transplant free survival at 3 months | 3 months | ||
Secondary | Association of baseline and change in liver and splenic stiffness with etiology of ACLF | Day 14 | ||
Secondary | Association of baseline liver and splenic stiffness with severity of ACLF by AARC-ACLF score, at presentation | Day 1 | ||
Secondary | Association of baseline liver and splenic stiffness with severity of ACLF by CLIF-C-ACLF score, at presentation | Day 1 | ||
Secondary | Association of baseline liver and splenic stiffness with severity of ACLF by MELD-Na at presentation | Day 1 | ||
Secondary | Association of baseline liver and splenic stiffness with severity of ACLF by CTP at presentation | Day 1 | ||
Secondary | Association of baseline liver and splenic stiffness with grade of esophageal varices in ACLF patients | 1-7 days | ||
Secondary | Association of baseline and change in liver and splenic stiffness with pattern of organ failures. | Day 14 | ||
Secondary | Association of changes in level of biochemical inflammatory markers with change in liver and splenic stiffness. | Day 14 | ||
Secondary | Association of change in liver and splenic stiffness with change in AARC-ACLF score. | Day 14 | ||
Secondary | Association of change in liver and splenic stiffness with change in CLIF-C-ACLF score. | Day 14 |
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