Viewing Study NCT01072643



Ignite Creation Date: 2024-05-05 @ 10:16 PM
Last Modification Date: 2024-10-26 @ 10:16 AM
Study NCT ID: NCT01072643
Status: TERMINATED
Last Update Posted: 2019-04-16
First Post: 2010-02-15

Brief Title: Sedation With Dexmedetomidine During Cardiac Catheterization
Sponsor: Aruna Nathan
Organization: Childrens Hospital of Philadelphia

Study Overview

Official Title: The Pharmacodynamics Safety and Pharmacokinetics of Sedation With Dexmedetomidine in Children Undergoing Hemodynamic Cardiac Catheterization With Special Reference to the Pulmonary Vascular Bed
Status: TERMINATED
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study was terminated due to increased PVR in one subject from T0-T1 reaching the level of a predetermined stopping rule
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance PVR The study will be conducted in 2 parts with part 1 incorporating stopping rules to optimize safety of the drug in this population The second part of this study will evaluate if the lowest safest dose as determined in part 1 is adequate to provide effective sedation during a cardiac catheterization procedure
Detailed Description: Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance The study will be conducted in 2 parts with a pilot phase incorporating stopping rules to optimize safety of the drug in this population Study subjects will include pediatric subjects with Pulmonary Hypertension PHTN

Part 1 This will be the dose escalation phase of the study Twenty four evaluable subjects will be enrolled Subjects will include pediatric subjects with pulmonary hypertension PVR4WU undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing Cohorts of 8 evaluable subjects will receive dose level 1 dose level 2 or dose level 3 of Dexmedetomidine DEX The dose will be escalated to the next dose of DEX once all subjects have been enrolled in the preceding DEX dose cohort and safety has been established at that level Inadequate sedation despite the highest dose of DEX at each level will be considered a treatment failure on an intention to treat basis Part 2 This part of the study will be conducted after the pilot phase is safely completed and the full complement of subjects will be recruited

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None