NCT07806565

Brief 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 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for phase_2

Timeline
55mo left

Started Jan 2027

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2030

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Heart Arrest

Keywords

naloxonein-hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • 30-day survival

    proportion of patients alive

    30 days after the cardiac arrest

Study Arms (2)

naloxone

ACTIVE COMPARATOR
Drug: naloxone

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

naloxoneDRUG

2 mg naloxone administered intravenously or intraosseously

naloxone
PlaceboDRUG

0.9% saline administered intravenously or intraosseously

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In-Hospital Cardiac Arrest
  • Age ≥ 18 years
  • Received at least one dose of adrenaline during CPR

You may not qualify if:

  • "Do-not-resuscitate"-order
  • Known/suspected pregnancy
  • Known objection by the patient to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Arrest

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Anna Lybeck, MD PhD

CONTACT

0771-11 14 44anna.lybeck@med.lu.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor & senior consultant, anesthetics and intensive care

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 8, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP