Augmented-Medication CardioPulmonary Resuscitation (AMCPR) trial: a study protocol for a randomized controlled trial.

Abstract

Objective Clinical trials on demodynamic-directed cardiopulmonary resuscitation have been limited. The aim of this study is to investigate whether Augmented-Medication CardioPulmonary Resuscitation (AMCPR) would improve the odds of return of spontaneous circulation (ROSC) in patients with out-of-hospital cardiac arrest. Methods This is a double-blind, single-center, randomized placebo-controlled trial that will be conducted in the emergency department of a tertiary, university-affiliated hospital in Seoul, Korea. A total of 148 adult patients with nontraumatic, nonshockable, out-of-hospital cardiac arrest who have an initial diastolic blood pressure above 20 mmHg will be randomly assigned to two groups of 74 patients (a 1:1 ratio). Patients will receive an intravenous dose of 40 IU of vasopressin with epinephrine, or a placebo with epinephrine. The primary endpoint is a sustained ROSC (over 20 minutes). Secondary endpoints are enhanced diastolic blood pressure, end-tidal carbon dioxide levels, acidosis, and lactate levels during resuscitation. Discussion AMCPR is a trial about tailored medication for select patients during resuscitation. This is the first randomized control trial to identify patients who would benefit from vasopressin for achieving ROSC. This study will provide evidence about the effect of administration of vasopressin with epinephrine to increase ROSC rate. Trial registration ClinicalTrials.gov identifier: NCT03191240. Registered on June 19, 2017.