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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Medical Treatment | Active Comparator | Antibiotics, nutrition and supportive treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival in both groups | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival in both groups. | 7 days | |
| Incidence or resolution of infection in both groups | 7 day | |
| Incidence or resolution of infection in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Rakesh Jagdish, MD | Contact | 01146300000 | dr.rkj.kapil@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Standard Medical Treatment | Other | Antibiotics, nutrition and supportive treatment |
|
| 14 day |
| Incidence or resolution of infection in both groups | 28 day |
| Number of participant with development of new organ failure in both groups. | 7 day |
| Number of participant with development of new organ failure in both groups. | 14 day |
| Number of participant with development of new organ failure in both groups. | 28 day |
| Adverse events in both groups. | 28 day |
| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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