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

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Enrolling

Conditions

Acute-On-Chronic Liver Failure
Refractory Ascites
Cirrhosis, Liver
Acute Kidney Injury
Ascites

Treatments

Diagnostic Test: Echocardiographic assessment

Study type

Observational

Funder types

Other

Identifiers

NCT05700708
NK-2020-2141

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Cirrhosis with Refractory Ascites
Treatment:
Diagnostic Test: Echocardiographic assessment

Trial contacts and locations

1

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Central trial contact

Madhumita Premkumar

Data sourced from clinicaltrials.gov

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