(1) To establish the pharmacokinetic profile of clonidine following oral administration in children with suspected GH deficiency. (2) To relate the pharmacokinetics of clonidine to the observed expected (GH-response, cortisol response, depth and…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pharmacokinetics of clonidine following oral administration
- Growth hormone response following oral administration of clonidine
- Cortisol response following oral administration of clonidine
- Sedation depth following clonidine oral administration, measured with
modified Ramsay Sedation Scale
- Hemodynamic and respiratory parameters (Blood Pressure, Heart Rate,
Transcutaneous oxygen saturation) following oral administration of clonidine
Secondary outcome
- Basal ACTH
- Heart rate variability
- QTc times before and after clonidine administration.
Background summary
Clonidine is frequently used in a Growth hormone stimulation test in children
with suspected growth hormone deficiency. After clonidine (stimulant of GH
secretion) administration, serum GH levels are measured until t=150 minutes
after clonidine administration. Although it is a widely accepted test which is
performed often in pediatric medicine, it does have adverse reactions, mainly
hypotension and sedation. In some cases, volume expansion is required to manage
hypotensive episodes. It is not known if these adverse reactions are serum
clonidine concentration dependent, age related, or if associated hormone
deficiencies play a role. A pharmacokinetic profile of clonidine after oral
administration in children has not previously been performed.
Study objective
(1) To establish the pharmacokinetic profile of clonidine following oral
administration in children with suspected GH deficiency. (2) To relate the
pharmacokinetics of clonidine to the observed expected (GH-response, cortisol
response, depth and duration of sedation, hemodynamic parameters) and untoward
effects.
Study design
Observational Cohort study
Study burden and risks
Risks: In our opinion no additional risk occurs as a result of study
participation. The adverse reactions to clonidine (sedation, hypotension) pose
a potential risk, but, clonidine is administered for diagnostic purposes
(patient care), not for study purposes. The same goes for the insertion of an
intravenous canula.
Burden: The burdensome aspects as a result of study participation are:
- increase in blood sample volume
- More frequent monitoring of hemodynamic parameters (more frequent blood
pressure measurement, pulsoximetry, and 3 ECG's)
- Length of stay (including fasting) increased by one hour.
In our opinion this can be viewed as minimal burden.
Note that the informed consent text explicitly states that study participation
can also stop 2,5 hours after clonidine administration, the regular duration of
the clonidine test.
Zernikedreef 10
2333 CL Leiden
Nederland
Zernikedreef 10
2333 CL Leiden
Nederland
Listed location countries
Age
Inclusion criteria
- Written informed consent from parents or legal guardian, in the case of a child aged 12 years or older written informed consent from both parents/legal guardian and the child;
- Patients must be 0-17 years of age;
- Patients must have an indication for a clonidine test to investigate a possible growth hormone deficiency, and this is to be decided by or under supervision of a staff paediatrician, paediatric endocrinologist or fellow
Exclusion criteria
None
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-003678-82-NL |
| CCMO | NL16059.058.07 |