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

NCT05434286 | Unknown

• 1 other identifier: IM-2020-2145
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• 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

Study Arms (1)

Cirrhosis/ACLF of any etiology

Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria.

Diagnostic Test: Echocardiographic assessment

Interventions

Echocardiographic assessment DIAGNOSTIC_TEST

POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin

Cirrhosis/ACLF of any etiology

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Cirrhosis of any Etiology
• Patient with acute kidney injury meeting HRS-AKI criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, National Capital Territory of Delhi, 160012, India

Location

Related Publications (2)

• 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: 29973706 RESULT

• 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.

  PMID: 37976391 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Hepatorenal Syndrome; Liver Cirrhosis; Acute-On-Chronic Liver Failure; Ascites

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Hepatology

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 28, 2022
• Study Start: December 15, 2021
• Primary Completion: March 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

IN (1)