Acute on Chronic Liver FailureNCT03754400
Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
A study testing Albumin and Standard Medical Treatment 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 AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the… 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?
- Albumin and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 10 Sep 2018to 30 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
- Age >18 years to 65 years
- ACLF patients
Who cannot join
- Patients who have already received albumin in last 1 week
- Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
- ,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
- Not given consent
- Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
- Pregnant/ HIV / HCC >2cm size
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- Alcoholic hepatitis eligible for steroids
- Previous known allergic/adverse reaction to albumin
- Any clinical condition which the investigator considers would make the patient unsuitable for the trial
- Patients who will receive palliative treatment only during their hospital admission
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
About this study
Official title: A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
The AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.
All ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Albumin, Standard Medical Treatment
- 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.
AlbuminBiological
All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
Standard Medical TreatmentOther
Antibiotics, nutrition and supportive treatment
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Experimental | All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day. Receives: Biological: Albumin; Other: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | Antibiotics, nutrition and supportive treatment. Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival in both groups
Measured: 28 days
Secondary outcomes (8)
Transplant free survival in both groups.
Measured: 7 days
Incidence or resolution of infection in both groups
Measured: 7 day
Incidence or resolution of infection in both groups
Measured: 14 day
Incidence or resolution of infection in both groups
Measured: 28 day
Number of participant with development of new organ failure in both groups.
Measured: 7 day
Number of participant with development of new organ failure in both groups.
Measured: 14 day
Number of participant with development of new organ failure in both groups.
Measured: 28 day
Adverse events in both groups.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start10 Sep 2018
- Primary completion30 Jul 2020 (estimated)
- Study completion30 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
- 200 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
- NCT03754400
- Sponsor's protocol ID
- ILBS-ACLF-02
- Status last verified
- Apr 2020
- First submitted
- 17 Nov 2018
- Last updated
- 8 Apr 2020
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
- ClinicalTrials.gov ID
- NCT03754400
- Acronym / sponsor ID
- ILBS-ACLF-02
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 27 Nov 2018 (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 AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.
All ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Experimental | Biological: Albumin, Other: Standard Medical TreatmentAll patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day. |
| Standard Medical Treatment | Active comparator | Other: Standard Medical TreatmentAntibiotics, nutrition and supportive treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years to 65 years
- ACLF patients
Key exclusion criteria (10 listed)
- Patients who have already received albumin in last 1 week
- Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
- ,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
- Not given consent
- Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
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 |
|---|---|---|
| AlbuminAll patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day. | Biological | Albumin |
| Standard Medical TreatmentAntibiotics, nutrition and supportive treatment | Other | Albumin, Standard Medical Treatment |
Primary outcome
Transplant free survival in both groups
Time frame: 28 days
8 secondary outcomes
Transplant free survival in both groups.
Time frame: 7 days
Incidence or resolution of infection in both groups
Time frame: 7 day
Incidence or resolution of infection in both groups
Time frame: 14 day
Incidence or resolution of infection in both groups
Time frame: 28 day
Number of participant with development of new organ failure in both groups.
Time frame: 7 day
Number of participant with development of new organ failure in both groups.
Time frame: 14 day
Number of participant with development of new organ failure in both groups.
Time frame: 28 day
Adverse events in both groups.
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Acute on Chronic Liver Failure
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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)
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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 Albumin and Standard Medical Treatment 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 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: status not confirmed, as of the sponsor's last update on 8 Apr 2020. 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 Rakesh Jagdish, MD (01146300000, dr.rkj.kapil@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 both groups (time frame: 28 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 8 Apr 2020.