The objective of the study is to karacterize Pharmacokinetics and pharmacodynamics of frequently and routinely used drugs in children and neonates undergoing ECMO treatment and ultimately to formulate dosing regimes for these drugs for patients…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patienten aan ECMO
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Karacterizing the Pharmacokinetics of different drugs (analgesia, sedatives,
antibiotics, inotropic agents, PGE5 inhibitor, and diuretics) routinely used in
patients undergoing ECMO.
Describing the relationship between pharmacokinetics and demografical,
physiological, pathophysiological factors like diagnosis, genotype, PRISM/PIM
scores, liver and kidney function
albumin concentrations, different ECMO modi, ECMO flow, dialysis,
bloodtransfusions and ventilator settings.
Secondary outcome
Karacterizing the relationship between pharmacokinetics and clinical effects of
the above mentioned medication.
Describing the relationship between pharmacodynamics and demografical,
physiological, pathophysiological factors.
Formulating dosing regimes for the studied medication for patients treated with
ECMO.
Background summary
Children treated with ECMO recieve a wide variety of medication. There is only
sparse data available on farmacokinetics and farmacodynamics of these drugs
during ECMO. Dosing regimens are empiric or are extrapolated from data gathered
from children and adult population not on ECMO.
Study objective
The objective of the study is to karacterize Pharmacokinetics and
pharmacodynamics of frequently and routinely used drugs in children and
neonates undergoing ECMO treatment and ultimately to formulate dosing regimes
for these drugs for patients undergoing ECMO treatment.
Study design
Prospective observational study. Medication will be administered following
local protocol and routine.
Study burden and risks
Patients recieve standard intensive care treatment and monitoring following
local clinical routine and protocols. Standardized bloodsamples for bloodgas
analysis, bloodcount, electrolytes, liver and kidney functiontests, and
coagulation will be preformed following normal protocol.
For this study extra bloodsamples will be drawn from the ECMO circuit or an
indwelling arterial catheter, to measure drug concentrations. On the first day
during ECMO a maximum amount of 18ml of blood will be drawn. On the following
days 6-9ml per 24 hours will drawn. MOst neonates on ECMO have a bodyweight of
3kg. Total circulating bloodvolume is 80ml/kg which comes down to 240ml for a
3kg newborn. Our neonatal ECMO system is primed with 250ml blood. Total
circulating bloodvolume of patient and ECMO system is 490ml. 18ml/day amounts
to bloodwithdrawel of less than 5% of the total circulating bloodvolume of the
patient and the ECMO system.
Urine samples from a trans urethral catheter and dialysis filtrate samples will
be drawn every 8 hours to measure drugs and drug metabolites.
dr molenwaterplein 60
3015 GJ Rotterdam
NL
dr molenwaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
neonates and children 0-18 year on ECMO
Exclusion criteria
Witheld informed consent
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 | NL14729.078.06 |