Cirrhosis, LiverNCT05700708
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
An observational study of Cirrhosis, Liver and Acute-On-Chronic Liver Failure, 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
- Cirrhosis, Liver, Acute-On-Chronic Liver Failure, Refractory Ascites
- What is being tested?
- Echocardiographic assessment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2022to 15 Jul 2024
- 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 Refractory Ascites definition as per International Ascites club. 1. Diuretic-resistant ascites 2. Diuretic-intractable ascites
Who may be able to join
- Cirrhosis of any Etiology
- Patient with Refractory Ascites
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.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, National Capital Territory of Delhi, 160012
Madhumita Premkumar, 01722754777, drmadhumitap@gmail.com
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 Refractory Ascites.
Read the detailed description
The decrease in systemic vascular resistance (SVR) and redistribution of blood volume with reduced intravascular volume compartment and third space fluid losses. Systemic vasodilatation is compensated by an increase in cardiac output (CO) in the initial stages of compensated cirrhosis. However, as the stage of liver cirrhosis progresses to decompensation, more prominent arterial vasodilatation and reduced SVR leads to a fall in CO. Thus, the cardiac homeostat is reset in a cirrhotic hyperdynamic circulation, wherein an increased heart rate, and therefore, increased cardiac output will no longer be able to compensate for the reduced mean arterial pressure (MAP), and decreased blood volumes in central venous territories.18 Consequent activation of vasoconstrictor systems including renin-angiotensin-aldosterone, vasopressin and the sympathetic nervous system comes into play to maintain the intravascular blood volume and pressure. These compensatory pathways cause an increase in sodium and water retention resulting in refractory ascites and hepatorenal syndrome (HRS). In critically ill patients with cirrhosis, the limited cardiac reserve is further stressed, CCM and heart failure may be diagnosed for the first time when the patient develops sepsis or septic shock.
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 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) in patients with cirrhosis ACLF and refractory ascites
Definition of CCM is as per updated CCMC criteria of 2020.
- Conditions
- Cirrhosis, Liver, Acute-On-Chronic Liver Failure, Refractory Ascites, Ascites, Acute Kidney Injury
- Being tested
- Echocardiographic assessment
- Keywords
- Ascites, Cirrhotic Cardiomyopathy, Acute kidney injury
- Medical subject headings
- Liver Cirrhosis, Acute-On-Chronic Liver Failure, Ascites, Acute Kidney Injury
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, midodrine, diuretics and domiciliary albumin
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis with Refractory Ascites | Not described 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 after albumin
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2.
The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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
Cardiac output measurement by echocardiography after albumin
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2.
The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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 1
Cardiac output measurement by echocardiography after albumin
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2.
The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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 2
Cardiac output measurement by echocardiography after albumin
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2.
The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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 3
Secondary outcomes (10)
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Measured: day 0
Change in NT Pro brain natriuretic peptide (BNP) level
Measured: day 0
Change in plasma renin activity level
Measured: day 0
Change in Galectin-3 level
Measured: day 0
IVC size and collapsibility changes after 20% albumin
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 after 20% albumin
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Measured: Day 2
Lung Ultrasound score change after 20% Albumin
Measured: Day 1
IVC size and collapsibility changes after 20% albumin
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Measured: Day 1
Lung Ultrasound score change after 20% Albumin
Measured: Day 0
Lung Ultrasound score change after 20% Albumin
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Nov 2022
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies 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
- 80 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
- NCT05700708
- Sponsor's protocol ID
- NK-2020-2141
- Status last verified
- Sep 2023
- First submitted
- 6 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29973706Larrue H, Vinel JP, Bureau C. Management of Severe and Refractory Ascites. Clin Liver Dis. 2021 May;25(2):431-440. doi: 10.1016/j.cld.2021.01.010. Epub 2021 Mar 11.
PubMed 33838859Cardenas A, Arroyo V. Refractory ascites. Dig Dis. 2005;23(1):30-8. doi: 10.1159/000084723.
PubMed 15920323Salerno F, Guevara M, Bernardi M, Moreau R, Wong F, Angeli P, Garcia-Tsao G, Lee SS. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. Liver Int. 2010 Aug;30(7):937-47. doi: 10.1111/j.1478-3231.2010.02272.x. Epub 2010 May 21.
PubMed 20492521Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.
PubMed 31342529
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 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 Refractory Ascites
- ClinicalTrials.gov ID
- NCT05700708
- Acronym / sponsor ID
- NK-2020-2141
- Conditions
- Cirrhosis, Liver, Acute-On-Chronic Liver Failure, Refractory Ascites, Ascites, Acute Kidney Injury
- Keywords
- Ascites, Cirrhotic Cardiomyopathy, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 26 Jan 2023 (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 Refractory Ascites.
Detailed description
The decrease in systemic vascular resistance (SVR) and redistribution of blood volume with reduced intravascular volume compartment and third space fluid losses. Systemic vasodilatation is compensated by an increase in cardiac output (CO) in the initial stages of compensated cirrhosis. However, as the stage of liver cirrhosis progresses to decompensation, more prominent arterial vasodilatation and reduced SVR leads to a fall in CO. Thus, the cardiac homeostat is reset in a cirrhotic hyperdynamic circulation, wherein an increased heart rate, and therefore, increased cardiac output will no longer be able to compensate for the reduced mean arterial pressure (MAP), and decreased blood volumes in central venous territories.18 Consequent activation of vasoconstrictor systems including renin-angiotensin-aldosterone, vasopressin and the sympathetic nervous system comes into play to maintain the intravascular blood volume and pressure. These compensatory pathways cause an increase in sodium and water retention resulting in refractory ascites and hepatorenal syndrome (HRS). In critically ill patients with cirrhosis, the limited cardiac reserve is further stressed, CCM and heart failure may be diagnosed for the first time when the patient develops sepsis or septic shock.
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 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) in patients with cirrhosis ACLF and refractory ascites
Definition of CCM is as per updated CCMC criteria of 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis with Refractory Ascites | – | Diagnostic Test: Echocardiographic assessment |
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 Refractory Ascites definition as per International Ascites club. 1. Diuretic-resistant ascites 2. Diuretic-intractable ascites
Key inclusion criteria (2 listed)
- Cirrhosis of any Etiology
- Patient with Refractory Ascites
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, midodrine, diuretics and domiciliary albumin | Diagnostic test | Cirrhosis with Refractory Ascites |
Primary outcome
Cardiac output measurement by echocardiography after albumin
Time frame: Day 0
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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
Cardiac output measurement by echocardiography after albumin
Time frame: Day 1
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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
Cardiac output measurement by echocardiography after albumin
Time frame: Day 2
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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
Cardiac output measurement by echocardiography after albumin
Time frame: Day 3
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The 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
10 secondary outcomes
Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
Time frame: day 0
Change in NT Pro brain natriuretic peptide (BNP) level
Time frame: day 0
Change in plasma renin activity level
Time frame: day 0
Change in Galectin-3 level
Time frame: day 0
IVC size and collapsibility changes after 20% albumin
Time frame: Day 0
IVC size and collapsibility changes after 20% albumin
Time frame: Day 2
Lung Ultrasound score change after 20% Albumin
Time frame: Day 1
IVC size and collapsibility changes after 20% albumin
Time frame: Day 1
Lung Ultrasound score change after 20% Albumin
Time frame: Day 0
Lung Ultrasound score change after 20% Albumin
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: 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.
- Background: PubMed 33838859Larrue H, Vinel JP, Bureau C. Management of Severe and Refractory Ascites. Clin Liver Dis. 2021 May;25(2):431-440. doi: 10.1016/j.cld.2021.01.010. Epub 2021 Mar 11.
- Background: PubMed 15920323Cardenas A, Arroyo V. Refractory ascites. Dig Dis. 2005;23(1):30-8. doi: 10.1159/000084723.
- Background: PubMed 20492521Salerno F, Guevara M, Bernardi M, Moreau R, Wong F, Angeli P, Garcia-Tsao G, Lee SS. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. Liver Int. 2010 Aug;30(7):937-47. doi: 10.1111/j.1478-3231.2010.02272.x. Epub 2010 May 21.
- Results publication: PubMed 31342529Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
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 Cirrhosis, Liver and Acute-On-Chronic Liver Failure, 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 21 Sep 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?
Contact Madhumita Premkumar (01722754777, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output measurement by echocardiography after albumin (time frame: Day 0). The study lists 4 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 NCT05700708, which also lists 5 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 21 Sep 2023.