An interventional study of Plasma Exchange and Standard Medical Treatment 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 65 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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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 5th largest by planned enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2024, is one of 23 with no phase, reaches primary completion later than 13 of the 16 other live ones, and was the 26th 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 65 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 190 is above the median of 73 across 96 interventional 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.
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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 |
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Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, from their registry updates:
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Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy.
Hypothesis: We hypothesize that detrimental complications which include secondary organ dysfunction (circulation, brain, respiration, and kidneys) in patients with acute on chronic liver failure may be related to defects in the host response, which may be responsible for the progression of the disease. Thus, understanding the pathophysiology of secondary organ dysfunction particularly the role of gut dysbiosis and metabolic adaptation of the host in patients with ACLF is essential for preventing and ameliorating the function of these organs which in turn would improve overall survival. Considering systemic inflammation induces metabolic adaptation, the role of TPE in preventing the development of secondary organ failures and biomarkers of response to therapy would be evaluated in patients with ACLF.
Key Objectives: Can we develop specific biomarkers of response to therapy to identify the right patient selection that could benefit from spontaneous survival and avoid a liver transplant? Primary Objective To study the role of therapeutic plasma exchange versus standard medical treatment in patients with ACLF on improving AARC grade by 1 at day 14.
Secondary Objectives
Interventions SMT Group: Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement. Nutritional therapy 25-30 kcal/kg/day, to reach at least 80% of this target, lactulose, bowel wash, albumin, terlipressin or norepinephrine, and antibiotics will be provided according to the local institutional guidelines. Anti-virals in hepatitis B reactivation and details of the type of antiviral will be included..
Patients with organ failures requiring organ support would be managed in the intensive care unit. Patients would be managed with the standard of care which will include the use of vasopressors (norepinephrine or terlipressin for maintaining mean arterial pressure >65 mm of Hg, non-invasive or invasive mechanical ventilation, renal replacement therapy ( intermittent or continuous renal replacement therapy) for standard renal indications. Patients would be fed enterally with the use of parenteral nutrition in patients wherein enteral nutrition is not tolerated. Intravenous low-dose hydrocortisone would be administered to patients with norepinephrine >0.25 ug/kg/min, according to Surviving Sepsis Campaign Guidelines 2021. The use of antioxidants (N-acetylcysteine) would be recorded.
Plasma exchange: Patients randomized to this group will receive plasma exchange on day 1 Response assessment will be done to assess the need for a second session from day 3-7 and subsequently every week till day 28. A minimum of 3 sessions would be considered in the first seven days. The duration of each session would be 3-4 hours. Patients with partial response (not meeting criteria for a complete response after 3 sessions) would be considered for additional sessions as decided by the treating physician until desired complete response, adverse effects, liver transplant, death, or clinical futility. The complete response will be defined as a sustained reduction in bilirubin and international normalized ratio without any clinical worsening requiring discontinuation of therapy. Failure of therapy would be defined as the development of adverse eff ects, new onset sepsis, or organ failure. In such patients, further sessions would be deferred. Blood access was established with a double-lumen catheter inserted into the patient's femoral or jugular vein.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On day 1 Response assessment will be done to assess the need for a second session from day 3-7 and subsequently every week till day 28. A minimum of 3 sessions would be considered in the first seven days. The duration of each session would be 3-4 hours. Patients with partial response (not meeting criteria for a complete response after 3 sessions) would be considered for additional sessions as decided by the treating physician until desired complete response, adverse effects, liver transplant, death, or clinical futility. The complete response will be defined as a sustained reduction in bilirubin and international normalized ratio without any clinical worsening requiring discontinuation of therapy. Failure of therapy would be defined as the development of adverse effects, new onset sepsis, or organ failure. In such patients, further sessions would be deferred. Blood access was established with a double-lumen catheter inserted into the patient's femoral or jugular vein.
Biological: Plasma Exchange
Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.
Other: Standard Medical Treatment
On day 1 Response assessment will be done to assess the need for a second session from day 3-7 and subsequently every week till day 28. A minimum of 3 sessions would be considered in the first seven days. The duration of each session would be 3-4 hours. Patients with partial response (not meeting criteria for a complete response after 3 sessions) would be considered for additional sessions as decided by the treating physician until desired complete response, adverse effects, liver transplant, death, or clinical futility. The complete response will be defined as a sustained reduction in bilirubin and international normalized ratio without any clinical worsening requiring discontinuation of therapy. Failure of therapy would be defined as the development of adverse effects, new onset sepsis, or organ failure. In such patients, further sessions would be deferred. Blood access was established with a double-lumen catheter inserted into the patient's femoral or jugular vein.
Patients randomized to SMT Group will be given standard medical therapy (SMT) only included as per requirement.
The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival
the measure is an ordinal variable with 3 categories as above (grade 1, 2 and 3) derived from AARC score from 5-15
Time frame: 28 days
Transplant-free survival at 28-days
Time frame: 28 days
The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28
Each organ failure will be defined based on the definition as yes or no. Depending on if the patient improves or progresses the information will be collected and analyzed.
Time frame: day 7, 14 and 28
the development of infection at day 7 and 14 in patients who had no infection
Time frame: day 7 and day 14
Duration of ICU and hospital stay
Time frame: 28 days
The proportion of patients developing adverse events will be compared between the two groups
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Dec 2027, 45 months later.
Of 32 interventional studies with no phase under Acute-On-Chronic Liver Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Acute-On-Chronic Liver Failure →
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