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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pieter De Cock, Pharm.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

University Hospital Ghent

Ghent, , Belgium