Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

Study Overview
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Brief Summary
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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.

Official Title
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Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Heart Arrest

Intervention / Treatment
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* Drug: Vasopressin, Arginine
* Drug: Methylprednisolone
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vasopressin and methylprednisolone<br>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). | Drug: Vasopressin, Arginine<br>* 20 IE of vasopressin per dose for a maximum of four doses (80 IU)<br>Drug: Methylprednisolone<br>* 40 mg methylprednisolone once<br>|
| Placebo Comparator: Placebo<br>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. | Drug: NaCl<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Return of Spontaneous Circulation | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes | During the cardiac arrest, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Survived 30 Days |  | At 30 days | 
| Number of Participants With a Favorable Neurological Outcome 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. | At 30 days |