LEOPARDS
Trial Details
- Trial statusRecruiting
- Study email contactLEOPARDS@imperial.ac.uk
- Chief InvestigatorDr Anthony Gordon
- Project managerDr Farah Al-Beidh
- SponsorImperial College London
- ISRCTN numberISRCTN12776039
- PhaseIIb
Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis
Design and Objective
The main objectives of this trial are: 1. To ascertain if levosimendan reduces the incidence and severity of organ dysfunction as compared to placebo in adult patients who have septic shock. 2. To identify the effect of levosimendan on individual organ function in septic shock. 3. To establish the safety profile and pharmacokinetics of levosimendan in this group of patients.
Key inclusion criteria
- Hypotension, despite adequate intravenous fluid resuscitation, requiring vasopressor infusion AND two of the following: - Fever (>38C) or hypothermia (<36C) - Tachycardia (heart rate >90 bpm) - Tachypnoea (respiratory rate >20 breaths per min or PaCO2 <4.3 kPa) or on mechanical ventilation - Abnormal leukocyte count (>12,000/<4000 cells/mm3)