Sedation With Dexmedetomidine During Cardiac Catheterization
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The Primary Endpoint Will be the Change in PVR in Wood Units [ Time Frame: For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours ] [ Designated as safety issue: Yes ]Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;
- Efficacy of Sedation With DEX [ Time Frame: Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours ] [ Designated as safety issue: Yes ]
- To Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension and Its Dependence on Baseline PVR [ Time Frame: Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year ] [ Designated as safety issue: Yes ]
- To Obtain Pharmacokinetic Data in This Population [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
- To Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr
This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) 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.
Other Name: Precedex
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 (PVR>4WU) 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. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072643
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Aruna T Nathan, MBBS||Children's Hospital of Philadelphia|