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

April 28, 2023 updated by: Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

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).

Study Overview

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delhi
      • Chandigarh, Delhi, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cirrhosis of any etiology, aged between 18-65 years, with hepatorenal syndrome (HRS-AKI).

Acute kidney injury (AKI) (increase in serum creatinine by 0.3 mg/dL in less than 48 hour or an increase in serum creatinine by 50% from a stable baseline reading within 3 months) has been proposed to characterize renal dysfunction in patients with cirrhosis, in which type 1 HRS would be reclassified as HRS-AKI.

Stage 1 AKI would be classified as an increase in serum creatinine level by 0.3 mg/dL or a 50% increase, whereas stages 2 and 3 AKI would be a doubling and tripling, respectively, of serum creatinine levels.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cirrhosis/ACLF of any etiology
Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria.
POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output measurement by echocardiography
Time Frame: Day 0, Day 2, Day 7.

Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0 and 48 hours after enrollment.

The cardiac output at 7 days after enrollment will also be documented. he 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, Day 2, Day 7.
IVC size and collapsibility changes
Time Frame: Day 0.
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Day 0.
IVC size and collapsibility changes
Time Frame: Day 2
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Day 2
IVC size and collapsibility changes
Time Frame: Day 7.
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Day 7.
Number of patients with Complete Response in HRS-AKI
Time Frame: Day 7
Complete response is defined as a reversal in AKI with a final serum Creatinine (sCr) value of ≤ 0.3 mg/dL of the baseline.
Day 7
Number of patients with Partial Response in HRS-AKI
Time Frame: Day 7
Partial response is defined as regression in the stage of AKI with a final sCr > 0.3 mg/dL above the baseline.
Day 7
Number of patients with Non-Response in HRS-AKI
Time Frame: Day 7
Non-responder is defined if the sCr did not decrease or increased from the baseline.
Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Time Frame: Day 0 and Day 7
Day 0 and Day 7
Change in NT Pro brain natriuretic peptide (BNP) level
Time Frame: Day 0 and Day 7
Day 0 and Day 7
Change in plasma renin activity level
Time Frame: Day 0 and Day 7
Day 0 and Day 7
Change in Galectin-3 level
Time Frame: Day 0 and Day 7
Day 0 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

March 15, 2023

Study Completion (Anticipated)

June 15, 2023

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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