Phase 4 N=5 Treatment

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

Pulmonary Arterial Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT05439460 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio) — 0.8; 0.75; 0.61; 0.73 Rp:Rs ratio — p=0.9

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Phenylephrine (Drug); Epinephrine (Drug); Arginine Vasopressin (Drug)
Age: Pediatric, Adult · 1+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio)	0.8; 0.75; 0.61; 0.73; 0.49; 0.6	0.9

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. --------------------------------------------------------------------------------

Eligibility Criteria

Inclusion Criteria

Patients presenting for cardiac catheterization procedure with a diagnosis of PAH either by previous cardiac catheterization or echocardiography

Exclusion Criteria

Children presenting for cardiac catheterization who do not have PAH;
Children with PAH but with intracardiac shunts

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05439460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.