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

NCT05700708 | Unknown DMC

• 1 other identifier: NK-2020-2141
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ascites; Cirrhotic Cardiomyopathy; Acute kidney injury

Outcome Measures

Primary Outcomes (4)

• Cardiac output measurement by echocardiography after albumin

  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

  Day 0

• Cardiac output measurement by echocardiography after albumin

  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

  Day 1

• Cardiac output measurement by echocardiography after albumin

  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

  Day 2

• Cardiac output measurement by echocardiography after albumin

  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

  Day 3

Secondary Outcomes (10)

• Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level

  day 0

• Change in NT Pro brain natriuretic peptide (BNP) level

  day 0

• Change in plasma renin activity level

  day 0

• Change in Galectin-3 level

  day 0

• IVC size and collapsibility changes after 20% albumin

  Day 0

Study Arms (1)

Cirrhosis with Refractory Ascites

Diagnostic Test: Echocardiographic assessment

Interventions

Echocardiographic assessment DIAGNOSTIC_TEST

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

Cirrhosis with Refractory Ascites

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis of any etiology, aged between 18-65 years, with Refractory Ascites definition as per International Ascites club. 1. Diuretic-resistant ascites 2. Diuretic-intractable ascites

You may qualify if:

• Cirrhosis of any Etiology
• Patient with Refractory Ascites

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, National Capital Territory of Delhi, 160012, India

RECRUITING

Related Publications (5)

• 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.

  PMID: 29973706 BACKGROUND

• 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.

  PMID: 33838859 BACKGROUND

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

  PMID: 15920323 BACKGROUND

• 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.

  PMID: 20492521 BACKGROUND

• 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.

  PMID: 31342529 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Acute-On-Chronic Liver Failure; Ascites; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Madhumita Premkumar

CONTACT

01722754777; drmadhumitap@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 26, 2023
• Study Start: November 15, 2022
• Primary Completion: November 15, 2023
• Study Completion: July 15, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

IN (1)