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Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01076816
Recruitment Status : Terminated (Poor inclusion rate.)
First Posted : February 26, 2010
Last Update Posted : October 4, 2011
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Drug: dexmedetomidine Procedure: Vital signs Procedure: blood sampling Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

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Arms and Interventions
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Intervention Details:
  • Drug: dexmedetomidine

    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.

  • Procedure: Vital signs
    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.
  • Procedure: blood sampling
    Blood sampling for pharmacokinetic modelling is limited to a maximum of 1,8 ml/kg (in line with the EMEA guidelines on maximum blood sampling in children). Pharmacokinetic parameters and influence of covariates on these parameters will be assessed by a population pharmacokinetic approach.

Outcome Measures
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Primary Outcome Measures :
  1. pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure [ Time Frame: 48 hours ]
  2. covariates contributing to a variability in exposure and response to dexmedetomidine [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. preliminary knowledge on the level of sedation provided by dexmedetomidine [ Time Frame: 48 hours ]
  2. preliminary knowledge of safety issues [ Time Frame: 48 hours ]
    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

  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients (m/f) admitted to the paediatric intensive care unit
  • expected to require at least 24h of mechanical ventilation
  • patient age : 1 month-15 years
  • patients with single-organ respiratory failure

Exclusion Criteria:

  • patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
  • no arterial catheter in place at inclusion
  • patients who have received another investigational drug within 30 days
  • patients on continuous infusion with neuromuscular blockers
  • patients with a life expectancy <72h
  • patients with a known allergy to lorazepam, midazolam and/or morphine
  • heart block
  • pre-existing bradycardia
  • hemodynamically unstable patients (Wernovsky index > 16 points) after full fluid replacement with crystalloid
  • patients with significant renal insufficiency (creatinine plasma level 1 month-5 year : > 1 mg/dl ; 5-10 years : >1.2 mg/dl; > 10 years : > 1.5 mg/dl)
  • patients with significant hepatic insufficiency (aspartate aminase >950 UI/L and prothrombin time < 60 or INR >1.4)
  • previous treatment with α2-adrenoreceptor agonist clonidine within 14 days
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076816


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Pieter De Cock, Pharm.D University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01076816    
Other Study ID Numbers: 2009/518
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011
Keywords provided by University Hospital, Ghent:
Patients with single-organ failure in need of mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action