- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434286
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Delhi
-
Chandigarh, Delhi, India, 160012
- PGIMER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cirrhosis/ACLF of any etiology
Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria.
|
POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Day 0, Day 2, Day 7.
|
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.
|
Day 0.
|
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.
|
Day 2
|
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.
|
Day 7.
|
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.
|
Day 7
|
Number of patients with Partial Response in HRS-AKI
Time Frame: Day 7
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Partial response is defined as regression in the stage of AKI with a final sCr > 0.3 mg/dL above the baseline.
|
Day 7
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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.
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Time Frame: Day 0 and Day 7
|
Day 0 and Day 7
|
Change in NT Pro brain natriuretic peptide (BNP) level
Time Frame: Day 0 and Day 7
|
Day 0 and Day 7
|
Change in plasma renin activity level
Time Frame: Day 0 and Day 7
|
Day 0 and Day 7
|
Change in Galectin-3 level
Time Frame: Day 0 and Day 7
|
Day 0 and Day 7
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Hepatic Insufficiency
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease
- Liver Diseases
- Liver Failure, Acute
- Renal Insufficiency
- End Stage Liver Disease
- Fibrosis
- Syndrome
- Liver Failure
- Acute-On-Chronic Liver Failure
- Liver Cirrhosis
- Ascites
- Acute Kidney Injury
- Hepatorenal Syndrome
Other Study ID Numbers
- IM-2020-2145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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