Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000246583
Ethics application status
Approved
Date submitted
15/06/2006
Date registered
19/06/2006
Date last updated
6/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alpha-2 agonists in cardiac kids
Scientific title
Pharmacokinetics and pharmacodynamics of alpha-2 adrenoceptor agonists in children undergoing cardiac surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children undergoing cardiac surgery 1225 0
Condition category
Condition code
Cardiovascular 1308 1308 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clonidine is given as a intravenous bolus dose (1-5micrograms/kg) once child is stable in the intensive care unit. Dexmedetomidine is given as an intravenous bolus over 15 minutes (1-4 micrograms/kg) once child is stable in intensive care.
The intervention group are all children (1day to 16 years) who have undergone cardiac surgery at Starship Childrens Hospital.
Intervention code [1] 1145 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 1788 0
Pharmacokinetics of clonidine in children.
Timepoint [1] 1788 0
Clonidine plasma concentrations will be determined at approximately 5 minutes, 3 hours and 8 hours following drug administration by assay of plasma
Primary outcome [2] 1789 0
Pharmacokinetics of dexmedetomidine in children.
Timepoint [2] 1789 0
Dexmedetomidine plasma concentrations will be determined at approximately 5 minutes, 3 hours and 8 hours following drug administration by assay of plasma
Secondary outcome [1] 3145 0
Pharmacodynamics of clonidine and dexmedetomidine in children.
Timepoint [1] 3145 0
Pharmacodynamic variables such as blood pressure, heart rate, morphine and benzodiazipine use will be measured hourly for 18 hours, time to extubation will also be noted.

Eligibility
Key inclusion criteria
All children presenting to ICU following cardiac surgery.
Minimum age
1 Days
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to alpha-2 drugs, haemodynamic instability, parental or child refusal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The first 50 children enrolled in the study will be given clonidine, the second 50 children enrolled in the study will be given dexmedetomidine. This will then be compared to historical data of patietns who have undergone cardiac surgery in the past
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 355 0
New Zealand
State/province [1] 355 0

Funding & Sponsors
Funding source category [1] 1434 0
Charities/Societies/Foundations
Name [1] 1434 0
Green Lane Research and Educational Fund
Country [1] 1434 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Anaesthesiology
98-100 Mountain Road
Epsom
Auckland
New Zealand
Country
New Zealand
Secondary sponsor category [1] 1268 0
None
Name [1] 1268 0
Nil
Address [1] 1268 0
Country [1] 1268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2807 0
Starship Childrens Hospital
Ethics committee address [1] 2807 0
Auckland
Ethics committee country [1] 2807 0
New Zealand
Date submitted for ethics approval [1] 2807 0
Approval date [1] 2807 0
23/02/2006
Ethics approval number [1] 2807 0
NTX/06/02/005

Summary
Brief summary
The primary purpose of the study is to determine the pharmacokinetics of intravenous clonidine and dexmedetomidine in children as this has not been determined before and will lead to more rational dosing. Once the child is enrolled in the study (following parental consent and child assent, if of age) the child is given a single dose of clonidine or dexmedetomidine once stable in the intensive care unit following surgery. Following administration of the drug, 3 blood samples will be taken at 5 minutes, 3 hours and 8 hours following drug administration. These blood samples will be assayed to determine the plasma concentration of clonidine or dexmedetomidine and allow the determination of the pharmacokinetic profile. Pharmacodynamic data will also be obtained. Blood pressure, heart rate, morphine and benzodiazipine useage will be determined from nursing flow charts and drug charts hourly. The time to extubation will also be noted. This will enable us to determine if clonidine or dexmedetomidine has any effect or BP, HR, analgesic and sedative use and time on mehcanical ventiation.
Trial website
Trial related presentations / publications
Potts AL, Larsson P, Eksborg S et al. Clonidine disposition n children; a population analysis. Pediatric Anesthesia. 2007; 17:924-933

Potts AL, Warman GR, Anderson BJ. Dexmedetomidine disposition in children; a population analysis. Pediatric Anesthesia. 2008;18:722-730
Public notes

Contacts
Principal investigator
Name 36258 0
Address 36258 0
Country 36258 0
Phone 36258 0
Fax 36258 0
Email 36258 0
Contact person for public queries
Name 10334 0
Amanda Potts
Address 10334 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland
Country 10334 0
New Zealand
Phone 10334 0
+64 9 3737599 extn 89305
Fax 10334 0
Email 10334 0
[email protected]
Contact person for scientific queries
Name 1262 0
Amanda Potts
Address 1262 0
Department of Anaesthesiology
University of Auckland
Private Bag 92019
Auckland
Country 1262 0
New Zealand
Phone 1262 0
+64 9 3737599 extn 89305
Fax 1262 0
Email 1262 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.