Dexmedetomidine to improve neurologic injury of patients after out-of-hospital cardiac arrest

ISRCTN ISRCTN69111582
DOI https://doi.org/10.1186/ISRCTN69111582
Clinical Trials Information System (CTIS) 2026-527007-21-00
Austrian Science Fund Grant number FWF KLIF KLP2907025
Sponsor Medical University of Vienna
Funder Austrian Science Fund
Submission date
13/07/2026
Registration date
15/07/2026
Last edited
14/07/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Christian Schoergenhofer
Scientific, Principal investigator, Public

Department of clinical pharmacology, Medical University of Vienna
Vienna
1180
Austria

+43 1 40400 29810
christian.schoergenhofer@meduniwien.ac.at

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentParallel
PurposeBasic science, Health services research, Treatment
Scientific titleDEXmedetomidine to Improve Neurologic Injury of patients after out-of-hospital cardiac arrest – a phase II randomized, double blind, placebo-controlled, parallel group trial
Study acronymDEX-INI
Study objectives
Ethics approval(s)

Not yet submitted

Health condition(s) or problem(s) studiedPatients after out-of-hospital cardiac arrest
InterventionParticipants 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 according to time to sustained circulation (≤30 minutes vs. >30 minutes) and the need for mechanical circulatory support (MCS). Allocation concealment will be ensured by identical study medication prepared by the hospital pharmacy, with investigators, treating clinicians, participants, outcome assessors, and data analysts remaining blinded throughout the study.

Intervention arm: Dexmedetomidine administered as a continuous intravenous infusion at 0.5 μg/kg/hour, initiated within 2 hours of hospital admission and continued for 24 hours, in addition to standard post-cardiac arrest care.

Control arm: Matching placebo (0.9% sodium chloride solution) administered as a continuous intravenous infusion with identical appearance, volume, and duration (24 hours), initiated within 2 hours of hospital admission, in addition to standard post-cardiac arrest care.

The active treatment period is 24 hours, followed by an observation period of 72 hours during hospitalization. Clinical follow-up assessments are performed at 30 days and 90 days after cardiac arrest to assess neurological outcome, survival, and quality of life.
Intervention typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)Dexmedetomidine
Primary outcome measure(s)
  1. 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
Key secondary outcome measure(s)
  1. 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
  2. Neurological injury, assessed via the ranked composite endpoint of death before 72 hours and serum S100β concentration; participants who die before 72 hours are assigned the worst outcome rank, measured using standard methods for a routine biomarker in the central laboratory at 72 hours after cardiac arrest
  3. Neurological injury measured using serum S100β 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
  4. Acute kidney injury, according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, measured using an assessment of serum creatinine and urine output, according to KDIGO criteria, from routine clinical data at the first 72 hours after cardiac arrest
  5. 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
  6. 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
  7. 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
  8. Neurological functional outcome measured using the Cerebral Performance Category (CPC) scale at 30 and 90 days after cardiac arrest
  9. 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
  10. 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
  11. 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
Completion date01/04/2029

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration120
Key inclusion criteria1. 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
Key exclusion criteria1. Expected death within 72 hours or expected survival to < 3 months
2. Known limitations to intesive care therapye and "Do Not Resuscitate" or "Allow Natural Death" orders
3. 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
4. Known pre-arrest CPC of 3 or 4
5. 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
6. Time to sustained circulation > 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
Date of first enrolment01/10/2026
Date of final enrolment01/10/2028

Locations

Countries of recruitment

  • Austria

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 1.0 21/06/2026 13/07/2026 No No
Statistical Analysis Plan version 1.0 21/06/2026 13/07/2026 No No

Additional files

49899_Protocol_v1.0_21June2026.pdf
Protocol file
49899_Protocol_v1.0_21June2026.pdf
Statistical Analysis Plan

Editorial Notes

14/07/2026: Study’s existence confirmed by the Austrian Science Fund, Austria.

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