Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure
Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.
Procedure: Vital signs
Procedure: blood sampling
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- covariates contributing to a variability in exposure and response to dexmedetomidine [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- preliminary knowledge on the level of sedation provided by dexmedetomidine [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- preliminary knowledge of safety issues [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine infusion
- knowledge of the contribution of the CYP2A6 and UDP-glucuronosyltransferase genotype (covariate) to the variability in exposure and response to dexmedetomidine [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
dexmedetomidine will be given max 48h. In case analgosedation is still needed after stop of the dexmedetomidine infusion, the treatment is switched to conventional analgosedation regimens.
Additional drugs are given to every inadequately sedated patient (assessed by regular Comfort scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076816
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|University Hospital Ghent|
|Principal Investigator:||Pieter De Cock, Pharm.D||University Hospital, Ghent|