DIAGNOSTIC_TEST
Echocardiographic assessment
POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
Status
Unknown
Phase
Not applicable
Enrollment
75
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 28, 2022
Study start
Dec 15, 2021
Primary completion
Mar 15, 2023
Study completion
Jun 15, 2023
Results posted
Not reported
Registry updated
May 1, 2023
Outcomes
What the study measures.
Primary outcomes
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
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.
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.
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 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.
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.
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.
Secondary outcomes
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Time frame · Day 0 and Day 7
Change in NT Pro brain natriuretic peptide (BNP) level
Time frame · Day 0 and Day 7
Change in plasma renin activity level
Time frame · Day 0 and Day 7
Change in Galectin-3 level
Time frame · Day 0 and Day 7
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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
Study locations
1 registered sites.
India. Showing up to 24 locations stored in the fast local snapshot.
PGIMER
Chandigarh, National Capital Territory of Delhi, India
Publications
Results and literature.
PMID 29973706 ↗Adebayo D, Neong SF, Wong F. Refractory Ascites in Liver Cirrhosis. Am J Gastroenterol. 2019 Jan;114(1):40-47. doi: 10.1038/s41395-018-0185-6.PMID 37976391 ↗Premkumar M, Kajal K, Reddy KR, Izzy M, Kulkarni AV, Duseja AK, Sihag KB, Divyaveer S, Gupta A, Taneja S, De A, Verma N, Rathi S, Bhujade H, Chaluvashetty SB, Roy A, Kumar V, Siddhartha V, Singh V, Bahl A. Evaluation of terlipressin-related patient outcomes in hepatorenal syndrome-acute kidney injury using point-of-care echocardiography. Hepatology. 2024 May 1;79(5):1048-1064. doi: 10.1097/HEP.0000000000000691. Epub 2023 Nov 16.
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