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).
NCT ID: NCT03754400
Last Updated: 2020-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-09-10
2020-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Albumin
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.
Albumin
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 Treatment
Antibiotics, nutrition and supportive treatment
Standard Medical Treatment
Antibiotics, nutrition and supportive treatment.
Standard Medical Treatment
Antibiotics, nutrition and supportive treatment
Interventions
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Albumin
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 Treatment
Antibiotics, nutrition and supportive treatment
Eligibility Criteria
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Inclusion Criteria
2. ACLF patients
Exclusion Criteria
2. Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
3. Not given consent
4. Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
5. Pregnant/ HIV / HCC \>2cm size
6. Alcoholic hepatitis eligible for steroids
7. Previous known allergic/adverse reaction to albumin
8. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
9. Patients who will receive palliative treatment only during their hospital admission
18 Years
65 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Other Identifiers
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ILBS-ACLF-02
Identifier Type: -
Identifier Source: org_study_id
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