Prognostic Significance of Acute Change in Liver and Splenic Stiffness in Patients of Acute on Chronic Liver Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Acute changes in liver and splenic stiffness on day 7 in patients of ACLF predicts liver transplant free survival at 3 months.
Study Overview
Brief Summary
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.
Detailed Description
Study Design 1 year prospective cohort study Hypothesis: We hypothesize that acute change in liver and splenic stiffness at 7th & 14 th day predicts outcome in ACLF patients
Aim and Objective - Primary objective: To study the change in liver and splenic stiffness values at day 7 from baseline at day 1 between those with or without transplant free survival at Day 90.
Secondary objectives:
- To study the change in liver and splenic stiffness values at day 14 from baseline at day 1 between those with or without transplant free survival at Day 90.
- To evaluate association of baseline and change in liver and splenic stiffness with different etiologies of ACLF
- To evaluate association of baseline liver and splenic stiffness with grade of esophageal varices in ACLF patients.
- To evaluate association of baseline and change in liver and splenic stiffness with pattern of organ failures.
- To evaluate association of changes in level of biochemical inflammatory markers with change in liver and splenic stiffness.
- To evaluate association of baseline liver and splenic stiffness with severity of ACLF by AARC-ACLF score,CLIF-C-ACLF score, MELD-Na and CTP at presentation.
- To evaluate change in liver and splenic stiffness with change in AARC-ACLF score and CLIF-C-ACLF score.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of ACLF as per APASL criteria between 18 to 70 years of age
- •Patient and attendants willing to give informed consent
Exclusion Criteria
- •Age <18 years and > 70 years
- •Survival less than 7 days
- •Cirrhosis with prior decompensation
- •Grade 3 ascites
- •Hepatic encephalopathy grade III &IV
- •HCC/SOL >2cm in liver
- •Patient with congestive heart failure
- •Patient with extrahepatic cholestasis
- •Portal vein thrombosis
- •BMI >30 kg/m2
- •Prior variceal endotherapy or ongoing beta blocker treatment for varices
- •Pregnant and lactating women
- •Patient with cardiac pacemaker
- •Critically ill patients
Outcomes
Primary Outcomes
Acute changes in liver and splenic stiffness on day 7 in patients of ACLF predicts liver transplant free survival at 3 months.
Time Frame: 3 months
Secondary Outcomes
- Association of change in liver and splenic stiffness with change in AARC-ACLF score.(Day 14)
- Acute changes in liver and splenic stiffness on day 14 in patients of ACLF predicts liver transplant free survival at 3 months(3 months)
- Association of baseline liver and splenic stiffness with grade of esophageal varices in ACLF patients(1-7 days)
- Association of change in liver and splenic stiffness with change in CLIF-C-ACLF score.(Day 14)
- Association of baseline liver and splenic stiffness with severity of ACLF by AARC-ACLF score, at presentation(Day 1)
- Association of baseline liver and splenic stiffness with severity of ACLF by CLIF-C-ACLF score, at presentation(Day 1)
- Association of changes in level of biochemical inflammatory markers with change in liver and splenic stiffness.(Day 14)
- Association of baseline liver and splenic stiffness with severity of ACLF by CTP at presentation(Day 1)
- Association of baseline and change in liver and splenic stiffness with etiology of ACLF(Day 14)
- Association of baseline and change in liver and splenic stiffness with pattern of organ failures.(Day 14)
- Association of baseline liver and splenic stiffness with severity of ACLF by MELD-Na at presentation(Day 1)