CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Phenylephrine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05439460
NCT05439460Phase 4Completed

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

Stanford University·interventional·Posted Jun 30, 2022·Updated Aug 5, 2022

In Brief

A Phase 4 clinical trial evaluating Phenylephrine, Epinephrine, and 1 other intervention for Pulmonary Arterial Hypertension. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Pulmonary arterial hypertension (PAH) is a disease where the blood pressure in the pulmonary arteries (PAP) is high. PAH increases the risk of adverse events, including death, during and or after procedures. The severity of baseline PAH correlates with the incidence of major complications, such that those with PAP higher than their systemic blood pressure (SBP) had a 8 fold increased risk of complications. These children present for procedures where an acute exacerbation of their chronic illness-termed Pulmonary Hypertensive (PH)crisis, can occur, often resulting in death if not detected and managed expeditiously. Unfortunately there is little data and no consensus in the pediatric literature on how PH crisis should be managed. \--------------------------------------------------------------------------------

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2022
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.0 years ago

Interventions

Phenylephrinedrug

5 subjects will get Phenylephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.

Epinephrinedrug

5 subjects will get Epinephrine during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 0.5-1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.

Arginine Vasopressindrug

5 subjects will get Arginine Vasopressin during cardiac catheterization in patient with known Pulmonary Arterial Hypertension.Dose will be 1ug/kg body weight. Pressures in the pulmonary artery will be measured before and after the drug administration.