An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS)

Imperial College of Science, Technology and Medicine (UK)0 个研究点目标入组 516 人开始时间: 2013年9月19日最近更新: 2019年2月11日

适应症

试验速览

•1. The target population includes adult patients (=18 years) who require vasopressor support for the management of sepsis despite fluid resuscitation
•2. Inclusion criteria will use the internationally-established consensus definitions of sepsis. In brief, fulfil 2 out of 4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
•2.1. Fever (>38 C) or hypothermia (< 36 C)
•2.2. Tachycardia (heart rate > 90 beats per minute)
•2.3. Tachypnoea (respiratory rate > 20 breaths per minute or PaCO2 < 4.3 kPa) or need for mechanical ventilation
•2.4. Abnormal leukocyte count [> 12,000 cells/mm3, < 4000 cells/mm3, or > 10% immature (band) forms]
•3. Hypotension, despite adequate intravenous fluid resuscitation, requiring treatment with a vasopressor infusion (e.g. noradrenaline/adrenaline/vasopressin analogue) for at least four hours and still having an ongoing vasopressor requirement at the time of randomisation.
•Target Gender: Male & Female

•The exclusion criteria are as follows:
•1. More than 24 hours since meeting all the inclusion criteria
•2. Endstage renal failure at presentation (previously dialysis-dependent)
•3. Severe hepatic impairment (Child-Pugh class C)
•4. A history of Torsades de Pointes
•5. Significant mechanical obstructions affecting ventricular filling or outflow or both
•6. Treatment limitation decision in place [e.g. Do not attempt resuscitation (DNAR) or not for ventilation/dialysis]
•7. Known or estimated weight of more than135kg
•8. Known to be pregnant
•9. Previous treatment with levosimendan within 30 days
•10. Known hypersensitivity to levosimendan or any of the excipients
•11. Known to have received another investigational medicinal product within 30 days or currently in another interventional trial that might interact with the study drug.

发起方

Imperial College of Science, Technology and Medicine (UK)