Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites

Recruiting

• Conditions: Acute Kidney Injury; Cirrhosis, Liver; Acute-On-Chronic Liver Failure; Refractory Ascites; Ascites
• Interventions: Diagnostic Test: Echocardiographic assessment

• Registration Number: NCT05700708
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately.

We will assess IVC dynamics, LV systolic function \[LV ejection fraction (EF) \& cardiac output (CO)\], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and Refractory Ascites.

Detailed Description

The decrease in systemic vascular resistance (SVR) and redistribution of blood volume with reduced intravascular volume compartment and third space fluid losses. Systemic vasodilatation is compensated by an increase in cardiac output (CO) in the initial stages of compensated cirrhosis. However, as the stage of liver cirrhosis progresses to decompensation, more prominent arterial vasodilatation and reduced SVR leads to a fall in CO. Thus, the cardiac homeostat is reset in a cirrhotic hyperdynamic circulation, wherein an increased heart rate, and therefore, increased cardiac output will no longer be able to compensate for the reduced mean arterial pressure (MAP), and decreased blood volumes in central venous territories.18 Consequent activation of vasoconstrictor systems including renin-angiotensin-aldosterone, vasopressin and the sympathetic nervous system comes into play to maintain the intravascular blood volume and pressure. These compensatory pathways cause an increase in sodium and water retention resulting in refractory ascites and hepatorenal syndrome (HRS). In critically ill patients with cirrhosis, the limited cardiac reserve is further stressed, CCM and heart failure may be diagnosed for the first time when the patient develops sepsis or septic shock.

Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis accurately. We will assess IVC dynamics, LV systolic function \[LV ejection fraction (EF) \& cardiac output (CO)\], and diastolic dysfunction (E/e', e' and E/A ratio) in patients with cirrhosis ACLF and refractory ascites

Definition of CCM is as per updated CCMC criteria of 2020.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Cirrhosis of any Etiology
• Patient with Refractory Ascites

Exclusion Criteria

• Hepatocellular carcinoma
• Patients with active variceal bleeding
• HIV or severe immunocompromised state
• Chronic kidney disease (CKD) on renal replacement therapy (RRT),
• Previous transjugular intra hepatic portosystemic shunt (TIPS)
• Porto-pulmonary hypertension,
• Coronary artery disease
• Congenital or valvular heart disease
• Prosthetic cardiac valves

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis with Refractory Ascites	Echocardiographic assessment	-

Primary Outcome Measures

Name	Time	Method
Cardiac output measurement by echocardiography after albumin	Day 3	Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2.; The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation.; Cardiac output(CO), Stroke volume (SV), Heart rate (HR); CO = \[SV \* HR\]/ 1000

Secondary Outcome Measures

Name	Time	Method
Change in Galectin-3 level	day 0
Change in plasma renin activity level	day 0
Lung Ultrasound score change after 20% Albumin	Day 2
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level	day 0
Change in NT Pro brain natriuretic peptide (BNP) level	day 0
IVC size and collapsibility changes after 20% albumin	Day 1	IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, Delhi, India