Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients

NCT ID: NCT06298656

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-10
• Study Completion Date: 2026-02-28

Brief Summary

Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study

Detailed Description

To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.

• To determine the best cut off to define acute hemodynamic response in ACLF patients

Primary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF

Secondary outcome -

(1) Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week

(b) Methodology

Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria

Baseline parameters that will be recorded:

1. Baseline characteristics:

2. History and etiology of liver disease

3. Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)

4. Clinical and demographic profile

5. Endoscopy

Stopping rule of study:

1. Progression to exclusion criteria

2. In case of hypotension(<90/60mmHg) or Heart Rate <60 after carvedilol

3. Potential liver transplant within 90 days

Conditions

Acute-On-Chronic Liver Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

It is an observational study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 yrs

2. ACLF diagnosis (AARC criteria)

Exclusion Criteria

1. Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l)

2. PVT

3. HCC

4. BCS

5. HE grades 2-4

6. NSBB therapy within 5 days

7. Pregnancy

8. Lactation

9. Planned for LT in the next 12 weeks

10. No consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Countries

India

Central Contacts

Dr Garvit Mundra, MD

Role: CONTACT

garvitmundrailbs@gmail.com

01146300000

Facility Contacts

Garvit Mundra, MD

Role: primary

garvitmundrailbs@gmail.com

01146300000

Other Identifiers

ILBS-ACLF-17

Identifier Type: -

Identifier Source: org_study_id