No registrations found.
ID
Source
Brief title
Health condition
Prolonged half-life
Midazolam
Elderly
Intensive care
Pharmacokinetics
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the pharmacokinetics of midazolam in elderly patients admitted to the ICU. A time versus midazolam blood level curve, in which RASS level and dose infused is visible, will be created.
Secondary outcome
- To determine the elimination half-life of midazolam in elderly patients on the ICU;
- To determine whether accumulation of midazolam occurs in elderly patients on the ICU;
- To determine the metabolic capacity of the liver by the ratio midazolam/1-hydroxy midazolam in elderly patients on the ICU.
- To gain basic insight in the effect of factors, that are present on the ICU such as: ldecreased kidney function, inflammatory state, cardiac function and body mass on the pharmacokinetic profile of midazolam.
Study objective
Hypothetically, the elimination half-life of midazolam in elderly intensive care patients is double prolonged.
Study design
A blood sample of 2 mL will be drawn before the start of the therapy. After starting therapy a 2 ml blood sample will be drawn at 6, 12, 18 and 24 hours. Then, every 24 hours a blood sample will be stored until cessation of midazolam therapy (no extra blood drawing; sample originating from standard of care). After finalization, 2ml blood samples are drawn at 0, 3, 6, 12, 18, 24, 30, 36, 48, and 72 hours.
Intervention
None
Inclusion criteria
ƒ{ Age >70 years ;
ƒ{
ƒ{ Admitted to the ICU and institution of invasive mechanical ventilation
Intravenously administration of midazolam;
ƒ{ Expected midazolam administration for at least 12 hours;
Exclusion criteria
ƒ{ Use of CYP3A4 inhibitors or inductors at the start of the study;
o Strong to very strong CYP3A4 inhibitors: boceprevir, clarithromycin, erythromycin, grapefruit juice, indinavir, itraconazole, ketoconazole, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole.
o Strong to very strong CYP3A4 inductors: carbamazepine, dabrafenib, rifampicin and Saint John`s-wort.
ƒ{ Patients participating in another study;
ƒ{ Prescription of other sedatives (except fentanyl);
ƒ{ Patients suffering from cerebral condition, that may influence RASS scores.
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 |
|---|---|
| NTR-new | NL7393 |
| NTR-old | NTR7601 |
| Other | ABR nummer : 65812 |