Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatorenal Syndrome
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of patients with Complete Response in HRS-AKI
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
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).
Investigators
Madhumita Premkumar
Associate Professor, Department of Hepatology
Post Graduate Institute of Medical Education and Research, Chandigarh
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
Outcomes
Primary Outcomes
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.
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
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.
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.
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.
Secondary Outcomes
- 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)