Acute Liver FailureNCT02718079
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
A study testing Plasma Exchange, Management of cerebral edema/intracranial hypertension: and Transfer to Intensive Care Unit in people with Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- Plasma Exchange, Management of cerebral edema/intracranial hypertension: and Transfer to Intensive Care Unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 30 Dec 2016to 18 Oct 2018
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.
Who cannot join
- Age <12 or > 75 years
- Hepato-Cellular Carcinoma
- Active untreated Sepsis/DIC
- Any evidence of active bleed secondary to coagulopathy
- Hemodynamic instability requiring high dose of Vasopressors
- Coma of non-hepatic origin.
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- Pregnancy
- Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score >3, or oxygen/steroid-dependent chronic obstructive pulmonary disease).
- Patients being taken up for liver transplant
- Refusal to participate in the study.
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 Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial
The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.
- Conditions
- Acute Liver Failure
- Being tested
- Plasma Exchange, Management of cerebral edema/intracranial hypertension:, Transfer to Intensive Care Unit, Prophylactic Antibiotics, Intubation of trachea
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma ExchangeBiological
Management of cerebral edema/intracranial hypertension:Other
Transfer to Intensive Care UnitOther
Prophylactic AntibioticsDrug
Intubation of tracheaOther
Administration of mannitol or 3% saline for severe elevation of Intra Cranial PressureOther
Volume ReplacementOther
Pressor SupportOther
N-acetyl-L-cysteineDrug
Correction of metabolic parametersOther
Correction of nutritionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Standard medical therapy with Plasma Exchange | Experimental | Plasma Exchange will be performed for consecutive days. Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. Receives: Biological: Plasma Exchange; Other: Management of cerebral edema/intracranial hypertension:; Other: Transfer to Intensive Care Unit; Drug: Prophylactic Antibiotics; Other: Intubation of trachea; Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure; Other: Volume Replacement; Other: Pressor Support; Drug: N-acetyl-L-cysteine; Other: Correction of metabolic parameters; Dietary Supplement: Correction of nutrition |
| Standard medical therapy alone | Active comparator | Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. Receives: Other: Management of cerebral edema/intracranial hypertension:; Other: Transfer to Intensive Care Unit; Drug: Prophylactic Antibiotics; Other: Intubation of trachea; Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure; Other: Volume Replacement; Other: Pressor Support; Drug: N-acetyl-L-cysteine; Other: Correction of metabolic parameters; Dietary Supplement: Correction of nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in both groups.
Measured: 21 days
Secondary outcomes (14)
Duration of Intensive Care Unit stay in both groups.
Measured: 21 days
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Measured: 48 hours
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Measured: day 5
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Measured: day 7
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Measured: 48 hours
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Measured: day 5
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Measured: day 7
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Measured: 48 hours
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Measured: Day 5
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Measured: Day 7
Effect on systemic haemodynamics in both groups.
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Measured: 24 hours
Effect on systemic haemodynamics in both groups.
Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).
Measured: 48 hours
Pro inflammatory cytokines profile in both groups.
Measured: 1 hour
Serum Endotoxin levels in both groups.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start30 Dec 2016
- Primary completion8 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Rakhi Maiwall, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718079
- Sponsor's protocol ID
- ILBS-ALF-03
- Status last verified
- Nov 2019
- First submitted
- 29 Feb 2016
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, Choudhury A, Mathur RP, Hidam A, Pati NT, Sharma MK, Kumar A, Sarin SK. Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Apr;20(4):e831-e854. doi: 10.1016/j.cgh.2021.01.036. Epub 2021 Jan 29.
PubMed 33524593
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT02718079
- Acronym / sponsor ID
- ILBS-ALF-03
- Conditions
- Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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 will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical therapy with Plasma Exchange | Experimental | Biological: Plasma Exchange, Other: Management of cerebral edema/intracranial hypertension:, Other: Transfer to Intensive Care Unit, Drug: Prophylactic Antibiotics, Other: Intubation of trachea, Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, Other: Volume Replacement, Other: Pressor Support, Drug: N-acetyl-L-cysteine, Other: Correction of metabolic parameters, Dietary Supplement: Correction of nutritionPlasma Exchange will be performed for consecutive days. Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. |
| Standard medical therapy alone | Active comparator | Other: Management of cerebral edema/intracranial hypertension:, Other: Transfer to Intensive Care Unit, Drug: Prophylactic Antibiotics, Other: Intubation of trachea, Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, Other: Volume Replacement, Other: Pressor Support, Drug: N-acetyl-L-cysteine, Other: Correction of metabolic parameters, Dietary Supplement: Correction of nutritionStandard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.
Key exclusion criteria (10 listed)
- Age <12 or > 75 years
- Hepato-Cellular Carcinoma
- Active untreated Sepsis/DIC
- Any evidence of active bleed secondary to coagulopathy
- Hemodynamic instability requiring high dose of Vasopressors
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 |
|---|---|---|
| Plasma Exchange | Biological | Standard medical therapy with Plasma Exchange |
| Management of cerebral edema/intracranial hypertension: | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Transfer to Intensive Care Unit | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Prophylactic Antibiotics | Drug | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Intubation of trachea | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Volume Replacement | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Pressor Support | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| N-acetyl-L-cysteine | Drug | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Correction of metabolic parameters | Other | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
| Correction of nutrition | Dietary supplement | Standard medical therapy alone, Standard medical therapy with Plasma Exchange |
Primary outcome
Survival in both groups.
Time frame: 21 days
14 secondary outcomes
Duration of Intensive Care Unit stay in both groups.
Time frame: 21 days
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time frame: 48 hours
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time frame: day 5
Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
Time frame: day 7
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time frame: 48 hours
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time frame: day 5
Improvement in SOFA (Sequential Organ Failure Assessment) score.
Time frame: day 7
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time frame: 48 hours
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time frame: Day 5
Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
Time frame: Day 7
Effect on systemic haemodynamics in both groups.
Time frame: 24 hours
Effect on systemic haemodynamics in both groups.
Time frame: 48 hours
Pro inflammatory cytokines profile in both groups.
Time frame: 1 hour
Serum Endotoxin levels in both groups.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Derived from this study: PubMed 33524593Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, Choudhury A, Mathur RP, Hidam A, Pati NT, Sharma MK, Kumar A, Sarin SK. Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Apr;20(4):e831-e854. doi: 10.1016/j.cgh.2021.01.036. Epub 2021 Jan 29.
- 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.
Dr Rakhi Maiwall, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Exchange, Management of cerebral edema/intracranial hypertension: and Transfer to Intensive Care Unit in people with Acute 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 20 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival in both groups. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718079, which also lists 1 linked publication.
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 20 Nov 2019.