Hepatorenal SyndromeNCT05434286
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
An observational study of Hepatorenal Syndrome and Cirrhosis, Liver, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatorenal Syndrome, Cirrhosis, Liver, Acute-On-Chronic Liver Failure
- What is being tested?
- Echocardiographic assessment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 15 Dec 2021to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cirrhosis of any Etiology
- Patient with acute kidney injury meeting HRS-AKI criteria
Who cannot join
- 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,
Show all 9Show fewer
- Coronary artery disease
- Congenital or valvular heart disease
- Prosthetic cardiac valves
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Echocardiographic assessment
- Medical subject headings
- Hepatorenal Syndrome, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic assessmentDiagnostic test
POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis/ACLF of any etiology | Cirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria. Receives: Diagnostic Test: Echocardiographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7
Secondary outcomes (4)
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Measured: Day 0 and Day 7
Change in NT Pro brain natriuretic peptide (BNP) level
Measured: Day 0 and Day 7
Change in plasma renin activity level
Measured: Day 0 and Day 7
Change in Galectin-3 level
Measured: Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start15 Dec 2021
- Primary completion15 Mar 2023
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434286
- Sponsor's protocol ID
- IM-2020-2145
- Status last verified
- Apr 2023
- First submitted
- 13 Jun 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29973706Premkumar 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.
PubMed 37976391
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05434286
- Acronym / sponsor ID
- IM-2020-2145
- Conditions
- Hepatorenal Syndrome, Cirrhosis, Liver, Acute-On-Chronic Liver Failure, AKI, Refractory Ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis/ACLF of any etiology | – | Diagnostic Test: Echocardiographic assessmentCirrhosis with hepatorenal syndrome-acute kidney injury (HRS-AKI) as per International Ascites Club criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cirrhosis of any Etiology
- Patient with acute kidney injury meeting HRS-AKI criteria
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic assessmentPOC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin | Diagnostic test | Cirrhosis/ACLF of any etiology |
Primary outcome
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.
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Results publication: PubMed 29973706Adebayo 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.
- Derived from this study: PubMed 37976391Premkumar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatorenal Syndrome and Cirrhosis, Liver, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output measurement by echocardiography (time frame: Day 0, Day 2, Day 7.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05434286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.