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

Active, not recruiting

• Conditions: Acute-On-Chronic Liver Failure; Hepatorenal Syndrome; AKI; Cirrhosis, Liver; Refractory Ascites
• Interventions: Diagnostic Test: Echocardiographic assessment

• Registration Number: NCT05434286
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-28
• Primary Completion: 2023-03-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Study Completion: 2023-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis/ACLF of any etiology	Echocardiographic assessment	Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria.

Primary Outcome Measures

Name	Time	Method
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.
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
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.
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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, Delhi, India