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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhosis/ACLF of any etiology | Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic assessment | Diagnostic Test | POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin |
|
| 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. |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Cirrhosis of any etiology, aged between 18-65 years, with hepatorenal syndrome (HRS-AKI).
Acute kidney injury (AKI) (increase in serum creatinine by 0.3 mg/dL in less than 48 hour or an increase in serum creatinine by 50% from a stable baseline reading within 3 months) has been proposed to characterize renal dysfunction in patients with cirrhosis, in which type 1 HRS would be reclassified as HRS-AKI.
Stage 1 AKI would be classified as an increase in serum creatinine level by 0.3 mg/dL or a 50% increase, whereas stages 2 and 3 AKI would be a doubling and tripling, respectively, of serum creatinine levels.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | National Capital Territory of Delhi | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29973706 | Result | 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. | |
| 37976391 | Derived | 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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Serum samples
| 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 |
| Change in plasma renin activity level |
| Day 0 and Day 7 |
| Change in Galectin-3 level | Day 0 and Day 7 |
| ID | Term |
|---|---|
| D006530 | Hepatorenal Syndrome |
| D008103 | Liver Cirrhosis |
| D065290 | Acute-On-Chronic Liver Failure |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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