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

NCT ID: NCT05700708

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-07-15

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis with Refractory Ascites

Echocardiographic assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Echocardiographic assessment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Madhumita Premkumar

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PGIMER

Chandigarh, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Madhumita Premkumar

Role: CONTACT

01722754777

Facility Contacts

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Madhumita Premkumar

Role: primary

01722754777

References

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Adebayo D, Neong SF, Wong F. Refractory Ascites in Liver Cirrhosis. Am J Gastroenterol. 2019 Jan;114(1):40-47. doi: 10.1038/s41395-018-0185-6.

Reference Type BACKGROUND
PMID: 29973706 (View on PubMed)

Larrue H, Vinel JP, Bureau C. Management of Severe and Refractory Ascites. Clin Liver Dis. 2021 May;25(2):431-440. doi: 10.1016/j.cld.2021.01.010. Epub 2021 Mar 11.

Reference Type BACKGROUND
PMID: 33838859 (View on PubMed)

Cardenas A, Arroyo V. Refractory ascites. Dig Dis. 2005;23(1):30-8. doi: 10.1159/000084723.

Reference Type BACKGROUND
PMID: 15920323 (View on PubMed)

Salerno F, Guevara M, Bernardi M, Moreau R, Wong F, Angeli P, Garcia-Tsao G, Lee SS. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. Liver Int. 2010 Aug;30(7):937-47. doi: 10.1111/j.1478-3231.2010.02272.x. Epub 2010 May 21.

Reference Type BACKGROUND
PMID: 20492521 (View on PubMed)

Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.

Reference Type RESULT
PMID: 31342529 (View on PubMed)

Other Identifiers

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NK-2020-2141

Identifier Type: -

Identifier Source: org_study_id

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