Sedation in Intensive Care Clinical Trial
Official title:
A Double Blind, Randomised, Multicentre, Active Controlled, Parallel-group, Phase III Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Intravenous Clonidine (Hydrochloride) Compared to Midazolam for Sedation in Children From Birth to Less Than 18 Years of Age
Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine
(hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18
years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical
ventilation and sedation for at least 24 hours.
In particular, the proportion of subjects with sedation failure at the maximum possible dose
(defined within the study protocol) will be measured. Additionally, the safety and
tolerability (including withdrawal effects) of clonidine compared to midazolam will be
evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU
will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics,
pharmacodynamics and metabolism will be also identified.
Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be
manufactured. At least 300 subjects will be enrolled from study centres in five European
member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden).
The clinical study will enrol critically ill paediatric patients who require mechanical
ventilation and sedation.
Subjects will be closely followed using standard PICU monitoring of vital functions
(continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent
assessment of systolic and diastolic blood pressure), intermittent assessment of pain and
depth of sedation, documentation of parameters of mechanical ventilation and intermittent
arterial blood gas analysis.
The study will be conducted in compliance with the study protocol, Good Clinical Practice
(ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff
will be monitoring subjects around the clock, thus minimising reaction time in case of alarms
or deterioration of clinical parameters.
This project has received funding from the European Union's Seventh Framework Programme for
research, technological development and demonstration under grant agreement n° 602453.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Completed |
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Phase 3 |