Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure. (NEODEX)
Clinical experience with dexmedetomidine in the paediatric population is limited. Critical illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.
Mechanically-ventilated Neonates With Single-organ Respiratory Failure.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dexmedetomidine Pharmacokinetics - Pharmacodynamics in Mechanically Ventilated Neonates With Single-organ Respiratory Failure (NEODEX).|
- pharmacokinetic parameters [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure.
- Covariates [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Covariates contributing to a variability in exposure and response to dexmedetomidine.
- level of analgosedation [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Preliminary knowledge on the level of analgosedation provided by dexmedetomidine.
- safety issues [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Preliminary knowledge of safety issues concerning 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.
- variability due to the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Knowledge of the contribution of the Cytochrome P450 2A6 (CYP2A6) and Uridine diphosphate (UDP)-glucuronosyltransferase genotype (covariate) to the variability in exposure and response to dexmedetomidine.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Dexmedetomidine will be given maximal 72 hours. 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-painful patient (assessed by regular Comfort-neo and Numeric Rating Scale scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed.
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, the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266252
|Contact: Pieter De Cock, Pharmacist||Pieter.Decock@uzgent.be|
|Bruges, Belgium, 8000|
|Contact: Wim Decaluwe, MD Wim.Decaluwe@azbrugge.be|
|Principal Investigator: Wim Decaluwe, MD|
|Ghent University Hospital||Recruiting|
|Ghent, Belgium, 9000|
|Principal Investigator: Piet Vanhaesebrouck, MD, PhD|
|Contact: Karel Allegaert, MD, PhD|
|Principal Investigator: Karel Allegaert, MD, PhD|
|Principal Investigator:||Piet Vanhaesebrouck, MD, PhD||Ghent University Hospital|