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

- 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.
- pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure [ Time Frame: 48 hours ]
- covariates contributing to a variability in exposure and response to dexmedetomidine [ Time Frame: 48 hours ]
- preliminary knowledge on the level of sedation provided by dexmedetomidine [ Time Frame: 48 hours ]
- 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
- 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 ]

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

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
Belgium | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
University Hospital Ghent | |
Ghent, Belgium |
Principal Investigator: | Pieter De Cock, Pharm.D | University Hospital, Ghent |
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 |
Patients with single-organ failure in need of mechanical ventilation |
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 |