Heart ArrestPhase 2/3naloxone-IHCANCT07806565
Naloxone for In-Hospital Cardiac Arrest
A Phase 2/3 study testing naloxone in people with Heart Arrest, run by Region Skane.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-Hospital Cardiac Arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during CPR
Who cannot join
- "Do-not-resuscitate"-order
- Known/suspected pregnancy
- Known objection by the patient to participate in the trial
- Previous inclusion in the trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Heart Arrest
- Being tested
- naloxone, Placebo
- Keywords
- naloxone, in-hospital cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naloxoneDrug
2 mg naloxone administered intravenously or intraosseously
PlaceboDrug
0.9% saline administered intravenously or intraosseously
| Study group | Role | What they receive |
|---|---|---|
| naloxone | Active comparator | Not described Receives: Drug: naloxone |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day survival
proportion of patients alive
Measured: 30 days after the cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Clinical Studies Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Principal investigator, Anna Lybeck, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806565
- Sponsor's protocol ID
- 2026-525323-24-00
- Other IDs
- 2026-525323-24-00
- Acronym
- naloxone-IHCA
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the last results, all de-identified individual patient data will be made available for data sharing. Data will be available for any research with ethical approval and with methodology approved by the steering committee of the current trial. Authorship of publications emerging from the shared data will follow standard authorship guidelines
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naloxone for In-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT07806565
- Acronym / sponsor ID
- naloxone-IHCA / 2026-525323-24-00
- Conditions
- Heart Arrest
- Keywords
- naloxone, in-hospital cardiac arrest
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Clinical Studies Sweden, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naloxone | Active comparator | Drug: naloxone |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In-Hospital Cardiac Arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during CPR
Key exclusion criteria (4 listed)
- "Do-not-resuscitate"-order
- Known/suspected pregnancy
- Known objection by the patient to participate in the trial
- Previous inclusion in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naloxone2 mg naloxone administered intravenously or intraosseously | Drug | naloxone |
| Placebo0.9% saline administered intravenously or intraosseously | Drug | placebo |
Primary outcome
30-day survival
Time frame: 30 days after the cardiac arrest
proportion of patients alive
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. After the publication of the last results, all de-identified individual patient data will be made available for data sharing. Data will be available for any research with ethical approval and with methodology approved by the steering committee of the current trial. Authorship of publications emerging from the shared data will follow standard authorship guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing naloxone in people with Heart Arrest, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Lybeck, MD PhD (0771-11 14 44, anna.lybeck@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day survival (time frame: 30 days after the cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.