Acute-On-Chronic Liver FailureNCT06387160
To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months.
An observational study of Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- as per institutional protocol
- How many people
- 480 participants
- Where
- 1 siteIndia
- Study dates
- 20 Apr 2024to 27 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Age - 18-75 years 2. Patients with ACLF(as per APASL guidelines)
Who may be able to join
- Age - 18-75 years
- Patients with ACLF(as per APASL guidelines) admitted in department of Hepatology.
- Acute Insult-Alcohol,HBV,Auto-immune hepatitis,Viral hepatitis,Drug Induced Liver Injury
Who cannot join
- Acute decompensation
- Complete portal vein thrombosis
- Hepatocellular carcinoma
- Tumoral portal vein thrombosis
- Chronic kidney disease
- Pregnancy
- Failure to give consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Shreyas Sarvesh, MD, 01146300000, shreyassarvesh@gmail.com
About this study
Official title: To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months-A Prospective Study.
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity <40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required.
Read the detailed description
Hypothesis:Baseline factors could reliably predict reversibility of ACLF, will help in improved clinical outcomes and risk stratifications.
Aim: To identify the predictors based on clinical, biochemical parameters and noninvasive tests to reliably predict reversibility of ACLF at 6 months
Methodology:
Study population:
- Age - 18-75 years
- Patients with ACLF(as per APASL guidelines) Study design:Prospective Cohort study done at Department of Hepatology,Institute of Liver and Biliary Sciences,New Delhi,India. The study will be conducted in Department of Hepatology .
Duration:2 year Sample size: Assuming that the expected reversibility of ACLF of 60% and desired confidence interval (CI) of 95%,alpha-5% and precision-5%,we need to enroll 370 cases. Considering 28-day mortality rate of around 30% in ACLF patients, we intend to prospectively enroll around 480 patients during the study period.
Monitoring and assessment All patients of ACLF, with acute insult as mentioned in our inclusion criteria, will be prospectively enrolled. Patients will receive standard of care for ACLF. During hospitalization, patients will undergo investigations as per institutional protocol and will receive standard of care as per there acute insult.
Once discharged, all patients will be managed in out-patients as mentioned in the study timeline (figure 1) and will undergo investigations as per the need for monitoring purpose. The list of investigations are mentioned in the figure 2 and is the usual institutional standard of care for medical management of ACLF patients.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- as per institutional protocol
- 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.
as per institutional protocolDrug
This is an observational study. Treatment will be given to the patients as per institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| ACLF | 1. Age - 18-75 years
2. Patients with ACLF(as per APASL guidelines) Receives: Drug: as per institutional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL]
Measured: 6 months
Secondary outcomes (9)
Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up
Measured: 3 and 6 months
Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months.
Measured: 28 days, 90-day and 6-months
Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months
Measured: 28 days, 90-day and 6-months
Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values
Measured: 3 and 6 months
Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days.
Measured: 3 months
Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months.
Measured: 6 months
Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year.
Measured: 1 year
Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year.
Measured: 1 year
Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 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
- NCT06387160
- Sponsor's protocol ID
- ILBS-ACLF-18
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months-A Prospective Study.
- ClinicalTrials.gov ID
- NCT06387160
- Acronym / sponsor ID
- ILBS-ACLF-18
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 26 Apr 2024 (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.
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity <40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required.
Detailed description
Hypothesis:Baseline factors could reliably predict reversibility of ACLF, will help in improved clinical outcomes and risk stratifications.
Aim: To identify the predictors based on clinical, biochemical parameters and noninvasive tests to reliably predict reversibility of ACLF at 6 months
Methodology:
Study population:
- Age - 18-75 years
- Patients with ACLF(as per APASL guidelines) Study design:Prospective Cohort study done at Department of Hepatology,Institute of Liver and Biliary Sciences,New Delhi,India. The study will be conducted in Department of Hepatology .
Duration:2 year Sample size: Assuming that the expected reversibility of ACLF of 60% and desired confidence interval (CI) of 95%,alpha-5% and precision-5%,we need to enroll 370 cases. Considering 28-day mortality rate of around 30% in ACLF patients, we intend to prospectively enroll around 480 patients during the study period.
Monitoring and assessment All patients of ACLF, with acute insult as mentioned in our inclusion criteria, will be prospectively enrolled. Patients will receive standard of care for ACLF. During hospitalization, patients will undergo investigations as per institutional protocol and will receive standard of care as per there acute insult.
Once discharged, all patients will be managed in out-patients as mentioned in the study timeline (figure 1) and will undergo investigations as per the need for monitoring purpose. The list of investigations are mentioned in the figure 2 and is the usual institutional standard of care for medical management of ACLF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACLF | – | Drug: as per institutional protocol1. Age - 18-75 years 2. Patients with ACLF(as per APASL guidelines) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age - 18-75 years 2. Patients with ACLF(as per APASL guidelines)
Key inclusion criteria (3 listed)
- Age - 18-75 years
- Patients with ACLF(as per APASL guidelines) admitted in department of Hepatology.
- Acute Insult-Alcohol,HBV,Auto-immune hepatitis,Viral hepatitis,Drug Induced Liver Injury
Key exclusion criteria (7 listed)
- Acute decompensation
- Complete portal vein thrombosis
- Hepatocellular carcinoma
- Tumoral portal vein thrombosis
- Chronic kidney disease
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 |
|---|---|---|
| as per institutional protocolThis is an observational study. Treatment will be given to the patients as per institutional protocol | Drug | ACLF |
Primary outcome
To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL]
Time frame: 6 months
9 secondary outcomes
Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up
Time frame: 3 and 6 months
Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months.
Time frame: 28 days, 90-day and 6-months
Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months
Time frame: 28 days, 90-day and 6-months
Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values
Time frame: 3 and 6 months
Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days.
Time frame: 3 months
Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months.
Time frame: 6 months
Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year.
Time frame: 1 year
Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year.
Time frame: 1 year
Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Acute-On-Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
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?
An observational study of 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 7 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 26 Apr 2024. 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 Shreyas Sarvesh, MD (01146300000, shreyassarvesh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL] (time frame: 6 months). 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 26 Apr 2024.