An observational study in Acute-On-Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India — 17 open to participants now, 17 under way, 2 of them phase 3. Acute-On-Chronic Liver Failure · Institute of Liver and Biliary Sciences, India.
Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, this one is the 2nd largest by planned enrollment of the 11 observational ones that give a count, is one of 4 that started in 2024, is one of 11 observational ones, reaches primary completion later than 4 of the 16 other live ones, and was the 28th registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →17 of the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India are open now, in 1 country. Recruiting first, the newest first:
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18+
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–75
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India
Ages 18+
By country, each count listing its studies:
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2011; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 480 is above the median of 235 across 65 observational studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 95 across the 28 interventional studies, 114 across the 11 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
4 of the studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06818565Institute of Liver and Biliary Sciences, IndiaComparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections. | 2026-12-31 |
| NCT07184866Institute of Liver and Biliary Sciences, IndiaVitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial | 2027-07 |
| NCT07178366Institute of Liver and Biliary Sciences, IndiaDouble Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) | 2027-07 |
| NCT07422948Institute of Liver and Biliary Sciences, IndiaEfficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. | 2027-08-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Age - 18-75 years 2. Patients with ACLF(as per APASL guidelines)
Drug: as per institutional protocol
This is an observational study. Treatment will be given to the patients as per institutional protocol
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Feb 2026, 22 months later.
Of 38 observational studies under Acute-On-Chronic Liver Failure, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acute-On-Chronic Liver Failure →
Institute of Liver and Biliary Sciences, India →