Cirrhosis With Sepsis
Conditions
Brief summary
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.
Interventions
BIOLOGICAL20% Albumin
OTHERPlasmalyte
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients of cirrhosis with suspected or documented sepsis with MAP \< 65 mm Hg
Exclusion criteria
* Age \<18 years or \> 75 yrs * Already received colloid or 2 litres of fluid within the first 12 hours of presentation * Already on vasopressors and/or inotropes * Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl * Patient with structural heart disease * On maintenance hemodialysis * Other causes of hypotension * Pregnant or lactating women * Patients in need for emergent surgical interventions * Known chronic obstructive lung disease and congestive heart failure * A previous adverse reaction to human albumin solution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversal of hypotension in both groups | 3 hours | Reversal is defined as Mean Arterial Pressure (MAP) \> 65 mmHg after 3 hours of resuscitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time during the first 28 days | 28 days | — |
| Proportion of patients with new organ failures. | 28 days | — |
| Mortality in both groups | 7 days | — |
| Requirement of renal-replacement therapy. | 28 days | Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy). |
| The duration of the Intensive Care Unit stay. | 28 days | — |
| Duration of mechanical ventilation. | 28 days | — |
Countries
India
Outcome results
None listed