Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Reversal of hypotension in both groups
Reversal is defined as Mean Arterial Pressure (MAP) \> 65 mmHg after 3 hours of resuscitation
Time frame: 3 hours
Mortality in both groups
Time frame: 7 days
Survival time during the first 28 days
Time frame: 28 days
Proportion of patients with new organ failures.
Time frame: 28 days
Duration of mechanical ventilation.
Time frame: 28 days
Requirement of renal-replacement therapy.
Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy).
Time frame: 28 days
The duration of the Intensive Care Unit stay.
Time frame: 28 days
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