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New treatment option for Out-Of-Hospital Cardiac Arrest
Official title The Danish Out-of-Hospital Cardiac Arrest Study
ClinicalTrials.gov ID: NCT05895838
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for out-of-hospital cardiac arrest.
Also referred to as Dexavit.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After resuscitation from Out-of-Hospital Cardiac Arrest (OHCA) patients experience Post Cardiac Arrest Syndrome due to ischemia and reperfusion injury. It consists of systemic inflammation, cerebral and myocardial dysfunction, and the condition that led to the arrest.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- OHCA of presumed cardiac cause
- Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes
- Unconsciousness (GCS \<9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
You likely can't join if
- Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window)
- Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
See the full eligibility criteria
- Age ≥18 years
- OHCA of presumed cardiac cause
- Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes
- Unconsciousness (GCS \<9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
- Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window)
- Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
- Known disease making 180 days survival unlikely
- Known pre-arrest CPC 3 or 4 functional status
- \>3 hours (180 minutes) from ROSC to screening
- Systolic blood pressure \<80 mm Hg despite fluid loading/vasopressor and/or inotropic medication (If the systolic blood pressure is recovering during the inclusion window of 180 minutes the patient may be included)
- Use of intra-aortic balloon pump/axial flow device/ECMO (If the patient is weaned and the device is removed during the inclusion window of 180 minutes the patient may be included)
- Temperature on admission \<30°C
- Known allergy for dexamethasone or olanzapine
- Ongoing (within 48 h) treatment with olanzapine or dexamethasone
- Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle
- Known or suspected Long QT Syndrome (LQTS)
- Known active fungal disease. Localized skin lesions do not exclude patients from inclusion
- Estimated body weight \<45kg
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region of Denmark, Denmark
- Aalborg, Denmark
- Aarhus, Denmark
- Køge, Denmark
- Odense, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region of Denmark, Denmark; Aalborg, Denmark; Aarhus, Denmark; Køge, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.