Patients after out-of-hospital cardiac arrest Circulatory System
Conditions
Interventions
Participants will be randomized in a 1:1 ratio to receive either dexmedetomidine or placebo. Randomization will be computer-generated using a centralized randomization schedule with stratification acc
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients = 18 years of age experiencing out-of-hospital cardiac arrest 2. Sustained ciruclation (defined as ROSC or successful eCPR flow lasting for at least 20 minutes) within 90 minutes of suspected collapse 3. Comatose (Glasgow Coma Scale <8) on admission or suspected in patients receiving sedatives 4. Start of the trial drug is possible within 2 hours of hospital admission 5. Subjected to temperature control 6. Combined no-flow and low-flow time of = 10 minutes
Exclusion criteria
Exclusion criteria: 1. Expected death within 72 hours or expected survival to 90 minutes 7. No-flow time > 10 minutes 8. Unwitnessed cardiac arrest unless the no-flow time can safely be assumed to be < 10 minutes 9. Unmanageable hemodynamic and respiratory instability albeit the use of vasopressors and/or mechanical circulatory support - at the discretion of the treating physicians 10. Known allergies or inolerances against any of the substances used in the trial 11. Requirements of acute surgery at screening 12. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurologic injury, assessed as the ranked composite endpoint of death before 72 hours and serum neuron-specific enolase (NSE) concentration; participants who die before 72 hours are assigned the worst outcome rank, measured using data collection and standard methods for a routine biomarker in the central laboratory at 72 hours after cardiac arrest | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypoxic liver injury, defined as a greater than 20-fold increase above the upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT), measured using routine liver biochemistry and standard laboratory analysis at the first 72 hours after cardiac arrest;Cardiac injury, assessed via cardiac biomarkers (e.g. cardiac troponin T and creatine kinase) in participants with acute coronary syndrome, measured using standard methods for a routine biomarker in the central laboratory at baseline, 6, 12, 24, 48 and 72 hours after cardiac arrest;Inflammatory response, assessed via C-reactive protein (CRP), interleukin-6 (IL-6), and exploratory inflammatory biomarkers, measured using standard methods for a routine biomarker in the central laboratory at baseline, 6, 12, 24, 48 and 72 hours after cardiac arrest;Neurological functional outcome measured using the Cerebral Performance Category (CPC) scale at 30 and 90 days after cardiac arrest;Functional disability and all-cause mortality measured using clinical assessment using the modified Rankin Scale (mRS) and ascertainment of survival status at 30 and 90 days after cardiac arrest;Health-related quality of life measured using the EQ-5D-5L, EQ visual analogue scale (EQ VAS), Hospital Anxiety and Depression Scale (HADS), Short Form-36 (SF-36), and Barthel Index at 90 days after cardiac arrest;Safety, assessed via the frequency of adverse events, serious adverse events, and adverse events of special interest, including clinically relevant bradycardia and haemodynamic instability requiring intervention, measured using clinical assessment and safety monitoring throughout the study observation period at the end of the 72-hour observation period;Neurological injury, assessed via serum neuron-specific enolase (NSE) concentration, measured using standard methods for a routine biomarker in the central laboratory at baseline, 6, 12, 24, 48 and 72 hours after cardiac arrest;Neurological injury, assessed via the | — |
Countries
Austria
Contacts
Public ContactChristian Schoergenhofer
Outcome results
None listed