DEXmedetomidine to Improve Neurologic Injury of patients after out-of-hospital cardiac arrest – a phase II randomized, double blind, placebo-controlled, parallel group trial

Medical University of Vienna0 个研究点目标入组 120 人开始时间: 2026年10月1日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•Adult patients = 18 years of age experiencing out-of-hospital cardiac arrest
•Sustained ciruclation (defined as ROSC or successful eCPR flow lasting for at least 20 minutes) within 90 minutes of suspected collapse
•Comatose (Glasgow Coma Scale <8) on admission or suspected in patients receiving sedatives
•Start of the trial drug is possible within 2 hours of hospital admission
•Subjected to temperature control
•Combined no-flow and low-flow time of = 10 minutes

•Expected death within 72 hours or expected survival to < 3 months
•Known limitations to intesive care therapye and "Do Not Resuscitate" or "Allow Natural Death" orders
•Advanced directive of patient to decline resuscitation, intensive care measures, or participation in a clinical trial according to the local legal requirements of participating trial sites
•Known pre-arrest CPC of 3 or 4
•Known diseases that may interfere with biomarkers indicative of neurological injury (e.g., cancer, inflammation, acute bleeding, stroke or infection of the central nervous system) at the discretion if the investigator
•Time to sustained circulation > 90 minutes
•No-flow time > 10 minutes
•Unwitnessed cardiac arrest unless the no-flow time can safely be assumed to be < 10 minutes
•Unmanageable hemodynamic and respiratory instability albeit the use of vasopressors and/or mechanical circulatory support - at the discretion of the treating physicians
•Known allergies or inolerances against any of the substances used in the trial
•Requirements of acute surgery at screening
•Pregnancy or breastfeeding

发起方