Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest
- Conditions
- Heart Arrest
- Interventions
- Registration Number
- NCT03640949
- Lead Sponsor
- Lars Wiuff Andersen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo NaCl The placebo for vasopressin will consist of 1 mL of 9 mg/mL NaCl ("normal saline") from 2 mL ampules identical to the vasopressin ampules. The placebo for methylprednisolone will also consist of 1 mL of 9 mg/mL NaCl. Vasopressin and methylprednisolone Vasopressin, Arginine The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU). Vasopressin and methylprednisolone Methylprednisolone The study drugs will consist of 40 mg methylprednisolone (Solu-medrol®, Pfizer) and 20 IU of vasopressin (Empressin®, Amomed Pharma GmbH) given as soon as possible after the first dose of adrenaline. Additional doses of vasopressin (20 IU) will be administered after each adrenaline dose for a maximum of four doses (80 IU).
- Primary Outcome Measures
Name Time Method Number of Participants With Return of Spontaneous Circulation During the cardiac arrest, an average of 20 minutes Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
- Secondary Outcome Measures
Name Time Method Number of Participants That Survived 30 Days At 30 days Number of Participants With a Favorable Neurological Outcome at 30 Days At 30 days A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
Trial Locations
- Locations (10)
Horsens Regional Hospital
🇩🇰Horsens, Denmark
Copenhagen University Hospital - Herlev
🇩🇰Herlev, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Copenhagen University Hospital - Gentofte
🇩🇰Hellerup, Denmark
Zealand University Hospital - Køge
🇩🇰Køge, Denmark
Randers Regional Hospital
🇩🇰Randers, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark