Acute-on-Chronic Liver Failure (ACLF)DPMAS-ACLFNCT07178366
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
A study testing Standard medical therapy (SMT) and Double Plasma Molecular Adsorption System (DPMAS) in people with Acute-on-Chronic Liver Failure (ACLF), run by Institute of Liver and Biliary Sciences, India.
Trial summary
Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-on-Chronic Liver Failure (ACLF)
- What is being tested?
- Standard medical therapy (SMT) and Double Plasma Molecular Adsorption System (DPMAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACLF patients of any etiology with systemic inflammatory response syndrome and AARC grade II or more.
Who cannot join
- Patients eligible for corticosteroids for severe alcohol-associated hepatitis related ACLF (other than hydrocortisone according to Surviving Sepsis Campaign Guidelines 2021 which is 50 mg iv q 6 h for management of refractory shock
- Hepatocellular carcinoma or any extrahepatic malignancy,
- Active fungal sepsis
- Disseminated intravascular coagulation
- Hemodynamic instability requiring norepinephrine >0.20ug/kg/min
- Patients with coma of non-hepatic origin
Show all 13Show fewer
- Patients with PaO2/FiO2 ratio <150
- Pregnancy
- Comorbidities associated with poor outcomes (severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease, chronic kidney disease) and patients with post-resection liver failure
- Patients with fibrinogen <110 and/or platelets less than 50,000
- Patients with oliguria with urine output less than 400 ml/day
- Lack of informed consent
- Patient enrolled in other clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Double Plasma Separation and Adsorption on Patients With Acute on Chronic Liver Failure- A Prospective Open-label Randomized Controlled Trial
Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Standard medical treatment can help, but many patients still do poorly without liver transplantation.
This study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.
Read more
In this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:
Standard medical therapy alone, or
Standard medical therapy plus DPMAS.
The main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.
The study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.
Read the detailed description
Acute-on-chronic liver failure (ACLF) is characterized by acute deterioration of liver function in patients with chronic liver disease, leading to systemic inflammation, organ failure, and high short-term mortality. Current treatment is largely supportive, and liver transplantation is often the only curative option, but many patients are not eligible or die while awaiting transplant.
Recent evidence suggests that systemic inflammation, bile acid accumulation, and damage-associated molecular patterns (DAMPs) play key roles in the progression of ACLF. Extracorporeal liver support systems such as plasma exchange have shown benefit in selected patients by reducing inflammation and improving short-term survival.
The Double Plasma Molecular Adsorption System (DPMAS) is a novel extracorporeal therapy that combines plasma separation with sequential adsorption columns. These columns are designed to remove bile acids, bilirubin, cytokines, and other toxins from the circulation. Early studies suggest that DPMAS may improve organ function and reduce mortality in ACLF.
This prospective, open-label, randomized controlled trial will compare standard medical therapy (SMT) alone versus SMT plus DPMAS in adult patients with ACLF (AARC grade II or higher). The primary outcome is an improvement in AARC grade by 1 at day 14 (7 days off treatment). Secondary outcomes include transplant-free survival at 28 days, changes in systemic inflammation, renal and hemodynamic function, bilirubin and bile acid levels, development of infections or new organ failures, and safety of the therapy.
A total of 56 participants will be enrolled and randomized equally into the two study groups. Patients in the intervention arm will undergo a minimum of two DPMAS sessions within the first seven days, with additional sessions as clinically indicated. Participants will be followed for up to 90 days for survival and clinical outcomes.
The study is investigator-initiated and conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India. Ethical approval has been obtained from the ILBS Institutional Ethics Committee.
- Conditions
- Acute-on-Chronic Liver Failure (ACLF)
- Being tested
- Standard medical therapy (SMT), Double Plasma Molecular Adsorption System (DPMAS)
- Keywords
- ACLF, DPMAS, Lactate, Sepsis, Liver support
- Medical subject headings
- Acute-On-Chronic Liver Failure, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical therapy (SMT)Other
Standard medical therapy includes nutritional support (25-30 kcal/kg/day), lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines.
Double Plasma Molecular Adsorption System (DPMAS)Device
DPMAS therapy uses extracorporeal liver support with two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). Minimum 2 sessions (3-4 hours each) are performed within the first 7 days, with additional sessions if partial response is observed.
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Therapy (SMT) Group | Active comparator | Participants will receive standard medical therapy alone, which may include nutritional support, lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines. Receives: Other: Standard medical therapy (SMT) |
| SMT + Double Plasma Molecular Adsorption System (DPMAS) | Experimental | Participants will receive standard medical therapy plus DPMAS therapy. DPMAS involves extracorporeal liver support using two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). A minimum of 2 sessions (3-4 hours each) will be given in the first 7 days, with additional sessions if partial response is observed. Receives: Other: Standard medical therapy (SMT); Device: Double Plasma Molecular Adsorption System (DPMAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in AARC ACLF grade by one at day 14 (after 7 days off treatment)
Proportion of participants who show an improvement of at least one grade in the Asian Pacific Association for the Study of the Liver acute-on-chronic liver failure (AARC ACLF) score at day 14, assessed after a treatment-free interval of 7 days from randomisation.
Measured: 14 days
Secondary outcomes (12)
Transplant-free survival
Proportion of participants alive without liver transplantation at 28 days after randomization.
Measured: 28 Days
Change in cytokine levels
Change in serum cytokine concentrations (IL-6, TNF-α, IL-10) measured by multiplex bead-based immunoassay (e.g., Luminex platform) from baseline to Day 14
Measured: 14 days
Change in DAMPs
Change in circulating damage-associated molecular patterns (HMGB1 and mitochondrial DNA) measured by ELISA and quantitative PCR, respectively, from baseline to Day 14
Measured: 14 days
Change in serum bilirubin levels
Change in serum bilirubin concentration from baseline to Day 14.
Measured: 14 days
Change in serum bile acid levels
Change in serum bile acid concentration from baseline to Day 14.
Measured: 14 days
Change in serum creatinine levels
Change in serum creatinine concentration from baseline to Day 14.
Measured: 14 days
Change in urine output
Change in urine output from baseline to Day 14
Measured: 14 days
Change in mean arterial pressure
Change in mean arterial pressure from baseline to Day 14
Measured: 14 days
Change in vasopressor requirement
Change in vasopressor requirement from baseline to Day 14
Measured: 14 days
Incidence of new infections
Number of participants who develop new infections during the follow-up period
Measured: 28 days
Development of new organ failures
Proportion of participants with new organ failures, assessed using the CLIF-OF score.
Measured: 28 days
Safety and tolerability of DPMAS
Incidence of adverse events such as hypotension, bleeding, sepsis, metabolic disturbances, or allergic reactions during therapy and follow-up.
Measured: Upto 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 May 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (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 Failure (ACLF)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio into two parallel groups. One group will receive standard medical therapy (SMT) alone, while the other group will receive SMT plus Double Plasma Molecular Adsorption System (DPMAS). Randomization will be open-label, and each participant will remain in the assigned group for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakhi Maiwall, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178366
- Sponsor's protocol ID
- IEC/2025/117/MA01
- Other IDs
- IEC Approval Number
- Acronym
- DPMAS-ACLF
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Double Plasma Separation and Adsorption on Patients With Acute on Chronic Liver Failure- A Prospective Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07178366
- Acronym / sponsor ID
- DPMAS-ACLF / IEC/2025/117/MA01
- Conditions
- Acute-on-Chronic Liver Failure (ACLF)
- Keywords
- ACLF, DPMAS, Lactate, Sepsis, Liver support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Sep 2025 (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.
Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Standard medical treatment can help, but many patients still do poorly without liver transplantation.
This study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.
In this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:
Standard medical therapy alone, or
Standard medical therapy plus DPMAS.
The main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.
The study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.
Detailed description
Acute-on-chronic liver failure (ACLF) is characterized by acute deterioration of liver function in patients with chronic liver disease, leading to systemic inflammation, organ failure, and high short-term mortality. Current treatment is largely supportive, and liver transplantation is often the only curative option, but many patients are not eligible or die while awaiting transplant.
Recent evidence suggests that systemic inflammation, bile acid accumulation, and damage-associated molecular patterns (DAMPs) play key roles in the progression of ACLF. Extracorporeal liver support systems such as plasma exchange have shown benefit in selected patients by reducing inflammation and improving short-term survival.
The Double Plasma Molecular Adsorption System (DPMAS) is a novel extracorporeal therapy that combines plasma separation with sequential adsorption columns. These columns are designed to remove bile acids, bilirubin, cytokines, and other toxins from the circulation. Early studies suggest that DPMAS may improve organ function and reduce mortality in ACLF.
This prospective, open-label, randomized controlled trial will compare standard medical therapy (SMT) alone versus SMT plus DPMAS in adult patients with ACLF (AARC grade II or higher). The primary outcome is an improvement in AARC grade by 1 at day 14 (7 days off treatment). Secondary outcomes include transplant-free survival at 28 days, changes in systemic inflammation, renal and hemodynamic function, bilirubin and bile acid levels, development of infections or new organ failures, and safety of the therapy.
A total of 56 participants will be enrolled and randomized equally into the two study groups. Patients in the intervention arm will undergo a minimum of two DPMAS sessions within the first seven days, with additional sessions as clinically indicated. Participants will be followed for up to 90 days for survival and clinical outcomes.
The study is investigator-initiated and conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India. Ethical approval has been obtained from the ILBS Institutional Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio into two parallel groups. One group will receive standard medical therapy (SMT) alone, while the other group will receive SMT plus Double Plasma Molecular Adsorption System (DPMAS). Randomization will be open-label, and each participant will remain in the assigned group for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Therapy (SMT) Group | Active comparator | Other: Standard medical therapy (SMT)Participants will receive standard medical therapy alone, which may include nutritional support, lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines. |
| SMT + Double Plasma Molecular Adsorption System (DPMAS) | Experimental | Other: Standard medical therapy (SMT), Device: Double Plasma Molecular Adsorption System (DPMAS)Participants will receive standard medical therapy plus DPMAS therapy. DPMAS involves extracorporeal liver support using two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). A minimum of 2 sessions (3-4 hours each) will be given in the first 7 days, with additional sessions if partial response is observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACLF patients of any etiology with systemic inflammatory response syndrome and AARC grade II or more.
Key exclusion criteria (13 listed)
- Patients eligible for corticosteroids for severe alcohol-associated hepatitis related ACLF (other than hydrocortisone according to Surviving Sepsis Campaign Guidelines 2021 which is 50 mg iv q 6 h for management of refractory shock
- Hepatocellular carcinoma or any extrahepatic malignancy,
- Active fungal sepsis
- Disseminated intravascular coagulation
- Hemodynamic instability requiring norepinephrine >0.20ug/kg/min
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 |
|---|---|---|
| Standard medical therapy (SMT)Standard medical therapy includes nutritional support (25-30 kcal/kg/day), lactulose, bowel wash, albumin, vasopressors (norepinephrine/terlipressin), antibiotics, antivirals for HBV reactivation, renal replacement therapy, and intensive care support as per institutional guidelines. | Other | SMT + Double Plasma Molecular Adsorption System (DPMAS), Standard Medical Therapy (SMT) Group |
| Double Plasma Molecular Adsorption System (DPMAS)DPMAS therapy uses extracorporeal liver support with two sequential hemoadsorption cartridges (BS330 ion exchange resin and HA330-II neutral macroporous adsorption resin). Minimum 2 sessions (3-4 hours each) are performed within the first 7 days, with additional sessions if partial response is observed. | Device | SMT + Double Plasma Molecular Adsorption System (DPMAS) |
Primary outcome
Improvement in AARC ACLF grade by one at day 14 (after 7 days off treatment)
Time frame: 14 days
Proportion of participants who show an improvement of at least one grade in the Asian Pacific Association for the Study of the Liver acute-on-chronic liver failure (AARC ACLF) score at day 14, assessed after a treatment-free interval of 7 days from randomisation.
12 secondary outcomes
Transplant-free survival
Time frame: 28 Days
Change in cytokine levels
Time frame: 14 days
Change in DAMPs
Time frame: 14 days
Change in serum bilirubin levels
Time frame: 14 days
Change in serum bile acid levels
Time frame: 14 days
Change in serum creatinine levels
Time frame: 14 days
Change in urine output
Time frame: 14 days
Change in mean arterial pressure
Time frame: 14 days
Change in vasopressor requirement
Time frame: 14 days
Incidence of new infections
Time frame: 28 days
Development of new organ failures
Time frame: 28 days
Safety and tolerability of DPMAS
Time frame: Upto 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical therapy (SMT) and Double Plasma Molecular Adsorption System (DPMAS) in people with Acute-on-Chronic Liver Failure (ACLF), run by Institute of Liver and Biliary Sciences, 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 1 inclusion and 13 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rakhi Maiwall, MBBS, MD, DM (+91 8750343085, rakhi_2011@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in AARC ACLF grade by one at day 14 (after 7 days off treatment) (time frame: 14 days). 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 25 Mar 2026.