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Albumin vs Saline for Sepsis-Induced Hypotension in Cirrhosis
NCT02462902Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2014
- Primary completion
- Jun 2015
- Countries
- 1
- Sponsor
- Institute of Liver and Biliary Sciences
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- albumin (human)
- Conditions
- septic shock
01
Overview
Phase 4, randomised, open-label trial of albumin (human) in septic shock (2 arms), sponsored by Institute of Liver and Biliary Sciences. Primary endpoint: Total number of patients with Mean Arterial Pressure (MAP) ≥ 65 mmHg at 3 hours. Started Feb 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
5% Albumin
250 ml 5% albumin over 15-30 mins
Normal Saline
30ml/kg 0.9% NaCl over 15-30 mins
03
Who it enrols
Adult patients with cirrhosis and sepsis-induced hypotension (MAP < 65 mmHg) not yet on vasopressors.
04
Endpoints
Primary
Total number of patients with Mean Arterial Pressure (MAP) ≥ 65 mmHg
Secondary
Change in lactate dynamics
Total number of patients with Urine output ≥ 0.5mL/kg/hr
Mortality
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