Prolonged half-life Midazolam Elderly Intensive care Pharmacokinetics
Conditions
Interventions
None
Sponsors
None
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Outcome results
None listed