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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Antibiotics, nutrition and supportive treatment
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGTransplant free survival in both groups
Time frame: 28 days
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
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