Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05439460
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2014-08-30
Brief Title:
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PHcrisis 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
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Detailed Description:
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 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 Over the last 10 years we have developed considerable expertise in managing children with PAH and preventing and treating their acute crisis using a medication called phenylephrine This medication is routinely used to increase the blood pressure in patients adults and children to treat hypotension Our theory has been that by increasing SBP we can increase the blood flow to the coronary arteries and prevent the right ventricle from failing acutely The latter results in catastrophic hypotension heart arrythmias and death There is no consensus or protocol guiding the management of the acute crisis This purpose of this study is to close that gap
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None