Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients

NCT06298656 | Not Yet Recruiting

• 1 other identifier: ILBS-ACLF-17
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (3)

• Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days

  90 days

• Transplant-free survival rate at 90 days

  90 days

• Correlation with evolution of AARC score by 2 week

  2 week

Interventions

No intervention OTHER

It is an observational study.

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

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

You may qualify if:

• Age 18-70 yrs
• ACLF diagnosis (AARC criteria)

You may not qualify if:

• Contraindications to NSBB (Heart rate \< 65 /min, BP \< 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na \< 125meq/l)
• PVT
• HCC
• BCS
• HE grades 2-4
• NSBB therapy within 5 days
• Pregnancy
• Lactation
• Planned for LT in the next 12 weeks
• No consent.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of 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 Garvit Mundra, MD

CONTACT

01146300000; garvitmundrailbs@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: March 10, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

IN (1)