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

Study Overview
=================
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).

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiographic assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measurement by echocardiography | 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 | 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 | 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 | 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 | 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 | 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 | Non-responder is defined if the sCr did not decrease or increased from the baseline. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) 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 | 
| Change in Galectin-3 level |  | Day 0 and Day 7 |