Refractory Hepatic EncephalopathyNCT03115697
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
A study testing Lactulose, Rifaximin and Plasmapheresis in people with Refractory Hepatic Encephalopathy, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Hepatic Encephalopathy
- What is being tested?
- Lactulose, Rifaximin and Plasmapheresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 7 Apr 2018to 15 Apr 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotics
- Age between 18-70 years
- Hepatic encephalopathy -Grade 3-4
- Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)
Who cannot join
- Concomitant participation in an other clinical trial
- Patient receiving sedatives(propofol,etc) 24 hours prior.
- Patients with severe cardiopulmonary disease
- Pregnancy
- Human Immunodeficiency Virus
- Hepatocellular Carcinoma or extrahepatic malignancy
Show all 12Show fewer
- Active uncontrolled sepsis with hemodynamic instability
- Chronic renal insufficiency on treatment with haemodialysis
- Uncontrolled bleed or patients in DIC
- Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support
- Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS).
- Patients with Non Hepatic Coma.
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
About this study
Official title: High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .
Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)
- Conditions
- Refractory Hepatic Encephalopathy
- Being tested
- Lactulose, Rifaximin, Plasmapheresis
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Lactulose 20 mL
RifaximinDrug
Rifaximin 550 BD
PlasmapheresisBiological
Plasmapheresis 8 hrly duration
| Study group | Role | What they receive |
|---|---|---|
| Lactulose with Rifaximin | Active comparator | Not described Receives: Drug: Lactulose; Drug: Rifaximin |
| Plasmapheresis | Experimental | Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days) Receives: Biological: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution in Hepatic Encephalopathy by 2 grades in both groups
Measured: Day 5
Secondary outcomes (5)
Improvement in Hepatic Encephalopathy in both groups
Measured: 2 years
Number of days of mechanical ventilation in both groups
Measured: 2 years
Survival in both groups
Measured: 28 days
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.
Measured: 2 years
Proportion of patients with failure of standard medical therapy in both groups.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start7 Apr 2018
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Why it stopped: lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Hepatic EncephalopathyStudies 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
- 0 participants (actual)
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
- NCT03115697
- Sponsor's protocol ID
- ILBS-HE-01
- Status last verified
- Nov 2019
- First submitted
- 12 Apr 2017
- Last updated
- 4 Nov 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03115697
- Acronym / sponsor ID
- ILBS-HE-01
- Conditions
- Refractory Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 14 Apr 2017 (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.
Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .
Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose with Rifaximin | Active comparator | Drug: Lactulose, Drug: Rifaximin |
| Plasmapheresis | Experimental | Biological: PlasmapheresisPlasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhotics
- Age between 18-70 years
- Hepatic encephalopathy -Grade 3-4
- Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)
Key exclusion criteria (12 listed)
- Concomitant participation in an other clinical trial
- Patient receiving sedatives(propofol,etc) 24 hours prior.
- Patients with severe cardiopulmonary disease
- Pregnancy
- Human Immunodeficiency Virus
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 |
|---|---|---|
| LactuloseLactulose 20 mL | Drug | Lactulose with Rifaximin |
| RifaximinRifaximin 550 BD | Drug | Lactulose with Rifaximin |
| PlasmapheresisPlasmapheresis 8 hrly duration | Biological | Plasmapheresis |
Primary outcome
Resolution in Hepatic Encephalopathy by 2 grades in both groups
Time frame: Day 5
5 secondary outcomes
Improvement in Hepatic Encephalopathy in both groups
Time frame: 2 years
Number of days of mechanical ventilation in both groups
Time frame: 2 years
Survival in both groups
Time frame: 28 days
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.
Time frame: 2 years
Proportion of patients with failure of standard medical therapy in both groups.
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose, Rifaximin and Plasmapheresis in people with Refractory Hepatic Encephalopathy, 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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 4 Nov 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution in Hepatic Encephalopathy by 2 grades in both groups (time frame: Day 5). 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 4 Nov 2019.