Hypothetically, the elimination half-life of midazolam in elderly intensive care patients is double prolonged.
ID
Bron
Verkorte titel
Aandoening
Prolonged half-life
Midazolam
Elderly
Intensive care
Pharmacokinetics
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
Hypothetically, the elimination half-life of midazolam in elderly intensive care patients is double prolonged.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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| Register | ID |
|---|---|
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| NTR-old | NTR7601 |
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