Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury

NCT ID: NCT05434286

Last Updated: 2023-05-01

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

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2023-06-15

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 ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).

Detailed Description

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Conditions

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Hepatorenal Syndrome Cirrhosis, Liver Acute-On-Chronic Liver Failure AKI Refractory Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis/ACLF of any etiology

Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria.

Echocardiographic assessment

Intervention Type DIAGNOSTIC_TEST

POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin

Interventions

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Echocardiographic assessment

POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Cirrhosis of any Etiology
* Patient with acute kidney injury meeting HRS-AKI criteria

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, Department of Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PGIMER

Chandigarh, National Capital Territory of Delhi, India

Site Status

Countries

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India

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 RESULT
PMID: 29973706 (View on PubMed)

Premkumar M, Kajal K, Reddy KR, Izzy M, Kulkarni AV, Duseja AK, Sihag KB, Divyaveer S, Gupta A, Taneja S, De A, Verma N, Rathi S, Bhujade H, Chaluvashetty SB, Roy A, Kumar V, Siddhartha V, Singh V, Bahl A. Evaluation of terlipressin-related patient outcomes in hepatorenal syndrome-acute kidney injury using point-of-care echocardiography. Hepatology. 2024 May 1;79(5):1048-1064. doi: 10.1097/HEP.0000000000000691. Epub 2023 Nov 16.

Reference Type DERIVED
PMID: 37976391 (View on PubMed)

Other Identifiers

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IM-2020-2145

Identifier Type: -

Identifier Source: org_study_id

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