AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

What Was Tested

In this phase 2 trial, researchers set out to test Vasopressin.

The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary Resuscitation: administration of additional vasopressin to titrate to arterial diastolic blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in out-of-hospital cardiac arrest patients.

It had two arms (groups): Vasopressins (experimental) and Normal saline (placebo comparator).

Additional normal saline intravenous injection for 2 times.

The registry classes the interventions as drug.

More on the Plan

Non-traumatic out-of-hospital cardiac arrest patients receive standard advanced cardiac life support according to the 2015 AHA guideline, including chest compression, intubation, ventilation, defibrillation, drug administration, including epinephrine and antiarrhythmic drugs if indicated, in the emergency department.

A research associate generates a random sequence using Excel software, and assignment of participants to their respective groups will be undertaken by the principal investigator.

Arterial line insertion is performed within 6 minutes after randomization and diastolic blood pressure will be monitored.

Arterial blood gas analysis will be analyzed for 5, 10, 15, and 20 minutes after arterial line insertion or termination of CPR.

Who Took Part

Enrollment: 110 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: trauma patients; age \< 18 years old; failed arterial line insertion within 6 minutes after randomization.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

The Vasopressin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2017-12-31 with completion listed for 2021-08-31.

It ran at 2 sites in South Korea (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Sustained return of spontaneous circulation (ROSC) (time frame: for 20 minutes after the time that participants had a palpable pulse).

It also tracked 6 secondary outcomes, for example Low level of neuron specific enolase level and Good neurological outcome based on Cerebral Performance Categories Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 110 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.