Acute-On-Chronic Liver FailureNCT04013113
Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
A study testing Haemoperfusion, Standard Medical Treatment and Plasma Exchange in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- Haemoperfusion, Standard Medical Treatment and Plasma Exchange
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- 9 Jul 2019to 31 Jul 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with ACLF as per APASL criteria will be included.
- Age : 18-65 yrs.
Who cannot join
- Patient with ischemic heart disease
- Patient with chronic obstructive disease.
- Patient with hepato cellular carcinoma.
- Patient with extra hepatic malignancy.
- Patient with chronic renal insufficiency.
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 Vinay Kumar, MD, 01146300000, drvinaybr@gmail.com
About this study
Official title: A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .
In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- Haemoperfusion, Standard Medical Treatment, Plasma Exchange
- 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.
HaemoperfusionDrug
Three sessions of Hemoperfusion, 1 plasma volume/session will be done to the selected patients.
Hemoperfusion will be done through bile acids and ammonia filters to adsorb bile acids and ammonia respectively.
Group specific fresh frozen plasma will be transfused to the patient through a peripheral vein catheter to prevent hypotension if required.
Standard Medical TreatmentDrug
Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
Plasma ExchangeOther
Fresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved.
The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier).
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Treatment | Active comparator | Group A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. Receives: Drug: Standard Medical Treatment |
| Hemoadsorption plus standard medical therapy | Experimental | Not described Receives: Drug: Haemoperfusion; Drug: Standard Medical Treatment |
| Plasma Exchange plus standard medical therapy | Experimental | Not described Receives: Drug: Standard Medical Treatment; Other: Plasma Exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival in all the group
Measured: day 28
Secondary outcomes (7)
Development of organ dysfunction in all the group
Measured: Day 7
Development of organ dysfunction in all the group
Measured: Day 15
Development of organ dysfunction in all the group
Measured: Day 28
New onset of sepsis in ll the groups
Measured: Day 7
New onset of sepsis in ll the groups
Measured: Day 15
New onset of sepsis in ll the groups
Measured: Day 28
Adverse Events in all the groups
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start9 Jul 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 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
- NCT04013113
- Sponsor's protocol ID
- ILBS-ACLF-03
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 10 Jul 2019
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04013113
- Acronym / sponsor ID
- ILBS-ACLF-03
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 9 Jul 2019 (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.
The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .
In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Treatment | Active comparator | Drug: Standard Medical TreatmentGroup A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. |
| Hemoadsorption plus standard medical therapy | Experimental | Drug: Haemoperfusion, Drug: Standard Medical Treatment |
| Plasma Exchange plus standard medical therapy | Experimental | Drug: Standard Medical Treatment, Other: Plasma Exchange |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with ACLF as per APASL criteria will be included.
- Age : 18-65 yrs.
Key exclusion criteria (5 listed)
- Patient with ischemic heart disease
- Patient with chronic obstructive disease.
- Patient with hepato cellular carcinoma.
- Patient with extra hepatic malignancy.
- Patient with chronic renal insufficiency.
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 |
|---|---|---|
| HaemoperfusionThree sessions of Hemoperfusion, 1 plasma volume/session will be done to the selected patients. Hemoperfusion will be done through bile acids and ammonia filters to adsorb bile acids and ammonia respectively. Group specific fresh frozen plasma will be transfused to the patient through a peripheral vein catheter to prevent hypotension if required. | Drug | Hemoadsorption plus standard medical therapy |
| Standard Medical TreatmentStandard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. | Drug | Hemoadsorption plus standard medical therapy, Plasma Exchange plus standard medical therapy, Standard Medical Treatment |
| Plasma ExchangeFresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved. The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier). | Other | Plasma Exchange plus standard medical therapy |
Primary outcome
Transplant free survival in all the group
Time frame: day 28
7 secondary outcomes
Development of organ dysfunction in all the group
Time frame: Day 7
Development of organ dysfunction in all the group
Time frame: Day 15
Development of organ dysfunction in all the group
Time frame: Day 28
New onset of sepsis in ll the groups
Time frame: Day 7
New onset of sepsis in ll the groups
Time frame: Day 15
New onset of sepsis in ll the groups
Time frame: Day 28
Adverse Events in all the groups
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Acute-On-Chronic Liver Failure
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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
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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.
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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. 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 Haemoperfusion, Standard Medical Treatment and Plasma Exchange 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 2 inclusion and 5 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 10 Jul 2019. 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 Vinay Kumar, MD (01146300000, drvinaybr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival in all the group (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 10 Jul 2019.