Patients admitted to the paediatric intensive care unit with single-organ respiratory failure
Conditions
Interventions
Trade Name: Precedex 100 µg/ml
Product Name: dexmedetomidine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775476
Concentration unit: µ
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients 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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 16 points) after full fluid replacement with cristalloid - paients 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 1.4) - previous treatment with a2-adrenoreceptor agonist clonidine within 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): PK analysis;Main Objective: - what are the pharmacokinetic parameters (distribution volume, distribution half-life, terminal half-life, context-sensitive half-life, clearance) of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure? - do size, age, co-medication, severity of illness, infusion length (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - knowledge of the pharmacokinetic parameters of dexmedetomidine and their covariates will allow targeted dosing in children;Secondary Objective: - does CYP2A6 and UDP-glucuronosyltransferase genotype (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? | — |
Countries
Belgium
Outcome results
None listed