Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest (VAM-IHCA)

Lars Wiuff Andersen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Heart Arrest

Treatments: Drug: Vasopressin, Arginine; Drug: NaCl; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03640949

00001

2017-004773-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. In-hospital cardiac arrest
2. Age ≥ 18 years
3. Received at least one dose of adrenaline during cardiopulmonary resuscitation

Exclusion criteria

1. Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
2. Prior enrollment in the trial
3. Invasive mechanical circulatory support at the time of the cardiac arrest
4. Known or suspected pregnancy at the time of the cardiac arrest

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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501 participants in 2 patient groups, including a placebo group

Vasopressin and methylprednisolone

Experimental group

Description:

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).

Treatment:

Drug: Vasopressin, Arginine

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: NaCl