Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients
NCT ID: NCT02509273
Last Updated: 2019-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
28 participants
INTERVENTIONAL
2016-05-31
2018-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries
NCT05790044
Effects of Daily Interruption of Sedatives in Critically Ill Children
NCT00441506
Clonidine in Femoral Nerve Block Surgery in Children
NCT01293149
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
NCT00580151
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients
NCT01170247
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CLONIDINE HYDROCHLORIDE
solution for i.v. infusion (maximum 55 μg/kg per day; maximum 7 day treatment)
Clonidine
MIDAZOLAM
solution for i.v. infusion (maximum 5.5 mg/kg per day; maximum 7 day treatment)
Midazolam
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clonidine
Midazolam
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged from birth (≥34 weeks gestational age \[GA\]) to \<17 years, 11 months, 1 week old
* Admitted or expected to be admitted (post-operatively) to PICU
* Existing or expected indication for invasive or non-invasive ventilation (except Continuous Positive Airway Pressure, CPAP)
* Anticipated need for continuous sedation for at least 24 hours
* Informed consent (or deferred consent) obtained from the subject's parent(s) or legal guardian(s)
* Where applicable, assent obtained from the subject to participate in the clinical trial
Exclusion Criteria
* Gestational age \[GA\] of \<34 weeks
* Body weight 3 kg or less AND aged 28 days or older
* Body weight less than 10 kg AND aged 2 years old or older
* Body weight greater than 85 kg
* Subjects who will be 18 years old in less than 3 weeks
* Known hypersensitivity to the IMP (clonidine) or comparator (midazolam), or Non Investigational Medicinal Product (morphine, propofol) or any of their formulation ingredients and their rescue medication
* Subjects anticipated to be treated with forbidden concomitant medications during IMP administration
* Subjects less than 24 hours post-resuscitation
* Subjects who have been under sedation for more than 72 hours immediately prior to assessment
* Subjects currently being treated with Extra Corporeal Membrane Oxygenation (ECMO)
* Subjects with treatment-induced whole body hypothermia
* Subjects with severe organ insufficiencies
* Subjects whose condition is assessed by the investigator to have an effect on the level of consciousness which impairs the assessment of sedation (COMFORT-B/NISS)
* Subjects with phaeochromocytoma
* Subjects with severe bradyarrhythmia resulting from either sick-sinus syndrome or atrioventricular (AV) block of 2nd or 3rd degree
* Known arterial hypertension requiring chronic treatment in medical history
* Females who are pregnant, lactating or planning to become pregnant or who return a positive result to a urine pregnancy test (a dipstick and serum pregnancy test will be performed at the screening visit).
* Employee or direct relative of an employee or any member of the study site staff or the Sponsor/ study management staff (applies to subject and/ or subject's parent(s)
* Participation in a clinical intervention study using drugs within the last 3 weeks
* Previous participation in this clinical study at any time
* Parent(s)/ legal guardian(s) decline to give informed consent. If parent(s)/ legal guardian(s) are not present
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasmus Medical Center
OTHER
University of Tartu
OTHER
Therakind Ltd
UNKNOWN
Gianni Benzi Pharmacological Research Foundation
OTHER
University College, London
OTHER
Karolinska Institutet
OTHER
Univerzita Karlova v Praze
OTHER
Vereniging Samenwerkende Ouder- En Patientenorganisaties
UNKNOWN
Bambino Gesù Hospital and Research Institute
OTHER
European Commission
OTHER
ARNAS Civico Di Cristina Benfratelli Hospital
OTHER
Servicio Madrileño de Salud, Madrid, Spain
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univerzita Karlova v Praze
Prague, , Czechia
Tallinn Children's Hospital
Tallinn, , Estonia
University of Erlangen-Nürnberg Medical School
Erlangen, , Germany
Diakonie Neuendettelsau - Cnopf'sche Kinderklinik Nürnberg
Nuremberg, , Germany
Azienda Ospedaliero Universitaria Policlinico di Bari
Bari, , Italy
ARNAS Civico Di Cristina Benfratelli
Palermo, , Italy
Bambino Gesù Hospital and Research Institute
Rome, , Italy
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Hospital Universitario 12 de Octubre
Madrid, , Spain
Karolinska Institutet
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Neubert A, Baarslag MA, Dijk MV, Rosmalen JV, Standing JF, Sheng Y, Rascher W, Roberts D, Winslade J, Rawcliffe L, Hanning SM, Metsvaht T, Giannuzzi V, Larsson P, Pokorna P, Simonetti A, Tibboel D; CLOSED Consortium. The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Jun 21;7(6):e016031. doi: 10.1136/bmjopen-2017-016031.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-003582-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLON01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.