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

• Sponsor: Postgraduate Institute of Medical Education and Research (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05434286
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatorenal Syndrome; Cirrhosis, Liver; Acute-On-Chronic Liver Failure; AKI; Refractory Ascites	Diagnostic Test: Echocardiographic assessment

Study Design

• Study Type: Observational
• Anticipated Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
• Actual Study Start Date: Mar 15, 2022
• Anticipated Primary Completion Date: Mar 15, 2023
• Anticipated Study Completion Date: Jun 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cardiac output measurement by echocardiography [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

2. IVC size and collapsibility changes [Day 0.]

   IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.

3. IVC size and collapsibility changes [Day 2]

   IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.

4. IVC size and collapsibility changes [Day 7.]

   IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.

5. Number of patients with Complete Response in HRS-AKI [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.

6. Number of patients with Partial Response in HRS-AKI [Day 7]

   Partial response is defined as regression in the stage of AKI with a final sCr > 0.3 mg/dL above the baseline.

7. Number of patients with Non-Response in HRS-AKI [Day 7]

   Non-responder is defined if the sCr did not decrease or increased from the baseline.

Secondary Outcome Measures

1. Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level [Day 0 and Day 7]

2. Change in NT Pro brain natriuretic peptide (BNP) level [Day 0 and Day 7]

3. Change in plasma renin activity level [Day 0 and Day 7]

4. Change in Galectin-3 level [Day 0 and Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PGIMER	Chandigarh	Delhi	India	160012

Sponsors and Collaborators

• Postgraduate Institute of Medical Education and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Madhumita Premkumar, Associate Professor, Department of Hepatology, Postgraduate Institute of Medical Education and Research
• ClinicalTrials.gov Identifier: NCT05434286
• Other Study ID Numbers: IM-2020-2145
• First Posted: Jun 28, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Failure; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Hepatorenal Syndrome; Acute Kidney Injury; Syndrome; Fibrosis; Ascites

Study Results

No Results Posted as of Jun 28, 2022