Relevancy of pharmacogenetic testing for optimizing sedative and analgesic drug therapy in critically ill children will be determined. Pharmacogenetic-based, individualized dosing strategies will be developed to optimize drug therapy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn en onrust
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the difference in dosage requirements of sedatives and
analgesics of patients with different genetic profiles for pain- and sedation
related genes.
Secondary outcome
Population pharmacokinetic-pharmacodynamic (PK-PD) will be used for modeling to
determine the impact of the polymorphisms on the relationship between dose,
blood drug concentration (PK) and sedation scores (PD: COMFORT scale, VAS
scale, BIS monitoring)
Background summary
Presentation of the problem: pharmacogenetic variation is associated with
increased risk of drug therapy failure or drug toxicity.
need for knowledge: Sedatives and analgesics are often prescribed to critically
ill children, who show wide variation in their response to these drugs.
Individual cases of drug therapy failure or toxicity in this population are
currently *brushed under the carpet*, while they could be explained by genetic
variation in drug handling and response.
proposed solution to the problem: an evaluation will be carried out in
critically ill children to determine how pharmacogenetic variation affects drug
response and explains part of observed adverse events and drug failure in
critically ill children receiving sedative and analgesic drugs.
Study objective
Relevancy of pharmacogenetic testing for optimizing sedative and analgesic drug
therapy in critically ill children will be determined. Pharmacogenetic-based,
individualized dosing strategies will be developed to optimize drug therapy.
Study design
observational study with minimal invasive procedures:
1. population pharmacokinetic-pharmacodynamic study
2. allelic frequency determination
Study burden and risks
Minimal blood sampling i.e. one sample per patient in all patients. In a
subgroup of patients repeated blood samples will be taken from an indwelling
arterial catheter for pharmacokinetic analysis. The study can only be carried
out in this population as results from adults or healthy children can not be
extrapolated to this group of patients (critically ill children)
Dr. Molenwaterplein 60
3015 GJ Rotterdam
Nederland
Dr. Molenwaterplein 60
3015 GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Children with a need for sedation and/or analgesia.
Exclusion criteria
Life expectancy less then 24 hours
ECMO
Design
Recruitment
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 |
|---|---|
| CCMO | NL12395.078.06 |