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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05700708
Enrollment
80
Registered
2023-01-26
Start date
2022-11-15
Completion date
2024-07-15
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Ascites, Cirrhotic Cardiomyopathy, Acute kidney injury

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.

Interventions

POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin, midodrine, diuretics and domiciliary albumin

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output measurement by echocardiography after albuminDay 0Echocardiographic 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

MeasureTime frameDescription
Change in Galectin-3 levelday 0
Change in NT Pro brain natriuretic peptide (BNP) levelday 0
Change in plasma renin activity levelday 0
IVC size and collapsibility changes after 20% albuminDay 0IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Lung Ultrasound score change after 20% AlbuminDay 1
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) levelday 0

Countries

India

Contacts

Primary ContactMadhumita Premkumar
drmadhumitap@gmail.com01722754777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026