| Registry | NCT07806565, acronym naloxone-IHCA |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 850 (Estimated) |
| Sponsor | Region Skane (Other); collaborators: Lund University, Clinical Studies Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research |
| Conditions | Heart Arrest |
| Interventions | naloxone, Placebo (Drug) |
| Dates | start 2027-01-01 (estimated), primary completion 2030-01-31 (estimated), completion 2031-07-01 (estimated), first posted 2026-09-08, last updated 2026-09-08 |
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All trials for Heart Arrest All trials of naloxone All trials of Placebo
The goal of this clinical trial is to learn if the drug naloxone in addition to cardiopulmonary resuscitation improves outcomes of in-hospital cardiac arrets. The main questions it aims to answer are:
Does naloxone improve survival after the cardiac arrest? Does naloxone improve functional outcome in survivors of cardiac arrest? Does naloxone improve health related quality of life after the cardiac arrest? How common are adverse reactions to naloxone when administered during cardiopulmonary resuscitation.
Researchers will compare naloxone to a placebo (a look-alike substance that contains no drug) to see if naloxone works during cardiac arrest.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| naloxone | Active comparator | Drug: naloxone | |
| placebo | Placebo comparator | Drug: Placebo |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. In-Hospital Cardiac Arrest 2. Age ≥ 18 years 3. Received at least one dose of adrenaline during CPR Exclusion Criteria: 1. "Do-not-resuscitate"-order 2. Known/suspected pregnancy 3. Known objection by the patient to participate in the trial 4. Previous inclusion in the trial