Acute on Chronic Liver FailureNCT05180292
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
A study testing Carvedilol 12.5 MG in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- Carvedilol 12.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis,
- Age 18-70 yrs
- Baseline HVPG ≥ 12 mmHg.
Who cannot join
- Contraindications to NSBB (heart rate < 65 /min, BP < 110/65 mm Hg, asthma, heart failure),
- Portal Vein Thrombosis,
- Hepatocellular carcinoma,
- HVOTO,
- HE grades 2-4,
- NSBB therapy within 5 days,
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- Pregnancy,
- Lactation,
- Planned for LT in the next 12 weeks
- No consent.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Chitranshu Vashishtha, DM, 01146300000, chitranshuv@gmail.com
About this study
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications [PHT related bleed, AKI, infections, HE] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Carvedilol 12.5 MG
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol 12.5 MGDrug
Carvedilol 12.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Acute on Chronic Liver failure | Experimental | Not described Receives: Drug: Carvedilol 12.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transplant free survival
Measured: Day 28
Secondary outcomes (3)
Complications [PHT related bleed, AKI, infections, HE] within 90 days
Measured: 90 days
Liver transplant-free survival rate
Measured: 90 days
Correlation with evolution of AARC score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start7 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180292
- Sponsor's protocol ID
- ILBS-ACLF-11
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
- ClinicalTrials.gov ID
- NCT05180292
- Acronym / sponsor ID
- ILBS-ACLF-11
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jan 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.
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications [PHT related bleed, AKI, infections, HE] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute on Chronic Liver failure | Experimental | Drug: Carvedilol 12.5 MG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis,
- Age 18-70 yrs
- Baseline HVPG ≥ 12 mmHg.
Key exclusion criteria (10 listed)
- Contraindications to NSBB (heart rate < 65 /min, BP < 110/65 mm Hg, asthma, heart failure),
- Portal Vein Thrombosis,
- Hepatocellular carcinoma,
- HVOTO,
- HE grades 2-4,
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 |
|---|---|---|
| Carvedilol 12.5 MGCarvedilol 12.5 mg | Drug | Acute on Chronic Liver failure |
Primary outcome
Liver transplant free survival
Time frame: Day 28
3 secondary outcomes
Complications [PHT related bleed, AKI, infections, HE] within 90 days
Time frame: 90 days
Liver transplant-free survival rate
Time frame: 90 days
Correlation with evolution of AARC score
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Acute on Chronic Liver Failure
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Very Low-volume Plasma Exchange in ACLF
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A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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?
A study testing Carvedilol 12.5 MG in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India 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 3 inclusion and 10 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 11 Jan 2022. 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 Dr Chitranshu Vashishtha, DM (01146300000, chitranshuv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transplant free survival (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.