Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation

What Was Tested

The trial (phase 1) is built around Vasopressin.

Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation, and unfortunately, survivors are often severely neurologically impaired.

This necessitates that resuscitation research must be conducted separately for pediatric and adult patients.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will be undertaken after consultation with and acceptance by the resuscitation committee and PICU at CMC.

SUMMARY OF STUDY PROCEDURES: When a patient experiences a CPA, standard Pediatric Advanced Life Saving (PALS) protocols will be followed.

This will include: establishment of an airway, support of breathing including supplemental oxygen, evaluation of cardiac rhythm, chest compressions, electrical defibrillation if appropriate, and administration of epinephrine as the first vasopressor medication.

The quality of CPR will be monitored and reported by the documenting nurse for the event, to include rate of ventilation, rate and depth of chest compressions, and no-flow time (time without chest compressions).

Who Took Part

130 planned participants were the target.

It was open to people of any sex aged up to 18 years.

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

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: do not attempt resuscitate (dnar) patients; chemical code only (i.e., no cpr/defibrillation); events not requiring chest compressions and/or defibrillation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Vasopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-04 with completion listed for 2010-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Vasopressin in 130 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.