Prognostic Significance of Acute Change in Liver and Splenic Stiffness in Patients of Acute on Chronic Liver Failure

NCT06069284 | Unknown

• 1 other identifier: ILBS-ACLF-12
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 and change in liver and splenic stiffness with etiology of ACLF

  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 baseline liver and splenic stiffness with severity of ACLF by MELD-Na at presentation

  Day 1

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients of ACLF admitted in Hepatology wards will be evaluated for inclusion criteria.

You may qualify if:

• Patients of ACLF as per APASL criteria between 18 to 70 years of age
• Patient and attendants willing to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Sudhir Kumar, MD

CONTACT

01146300000; sudhirkgmu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 5, 2023
• Study Start: September 25, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)