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Pharmacokinetics of midazolam in the elderly on the Intensive Care Unit: a pilot study

Pharmacokinetics of midazolam in the elderly on the Intensive Care Unit: a pilot study - MIKIEL - pilot

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45744
Enrollment
10
Registered
2019-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Situaties waarbij sedatie op de IC nodig is artificial sleep conditions Sedation need

Interventions

None listed

Sponsors

Intensive Care
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >70 years ; Admitted to the ICU and institution of invasive mechanical ventilation Intravenously administration of midazolam; Expected midazolam administration for at least 12 hours;

Exclusion criteria

Exclusion criteria: 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. Patients participating in another study; Prescription of other sedatives (except fentanyl); Patients suffering from cerebral condition, that may influence RASS scores.

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: The pharmacokinetic profile of midazolam in elderly patients on the ICU.

Secondary

MeasureTime 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)