Phase 3
N=501
Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
Heart Arrest
Bottom Line
View on ClinicalTrials.gov: NCT03640949 ↗Enrolled (actual)
501
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Return of Spontaneous Circulation — 100; 86 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vasopressin, Arginine (Drug); Methylprednisolone (Drug); NaCl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lars Wiuff Andersen
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Return of Spontaneous Circulation |
100; 86 | — |
| SECONDARY Number of Participants That Survived 30 Days |
23; 31 | — |
| SECONDARY Number of Participants With a Favorable Neurological Outcome at 30 Days |
18; 20 | — |
Summary
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
Eligibility Criteria
Inclusion Criteria
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
Exclusion Criteria
- Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
- Prior enrollment in the trial
- Invasive mechanical circulatory support at the time of the cardiac arrest
- Known or suspected pregnancy at the time of the cardiac arrest
Data sourced from ClinicalTrials.gov (NCT03640949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.