Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension

What Was Tested

The trial (phase 4) is built around Vasopressin.

Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary arteries (PAP) is high.

It had three arms (groups): Phenylephrine (experimental), Epinephrine (experimental) and Arginine Vasopressin (experimental).

Phenylephrine will be administered once the child is under anesthesia and the interventional cardiologist has measured the pressures in the pulmonary artery.

Epinephrine will be administered once the child is under anesthesia and the interventional cardiologist has measured the pressures in the pulmonary artery.

Arginine Vasopressin will be administered once the child is under anesthesia and the interventional cardiologist has measured the pressures in the pulmonary artery.

The registry classes the interventions as drug.

More on the Plan

Unfortunately there is little data and no consensus in the pediatric literature on how PH crisis should be managed.

There is no consensus or protocol guiding the management of the acute crisis.

This purpose of this study is to close that gap.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 1 Year up to 18 years.

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

Examples of who could join: Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: children presenting for cardiac catheterization who do not have pah;; children with pah but with intracardiac shunts.

How the Study Was Run

It was run as a non-randomized, sequential and open-label study.

Being open-label, the Vasopressin study did not mask who received what.

It started in 2012-01 with completion listed for 2014-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio) (time frame: Day 1 (at baseline and up to 5 minutes following study drug administration) (Q: 2 minutes - 2 to 5 minutes?)).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Vasopressin in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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