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

• Conditions: Prolonged half-lifeMidazolamElderlyIntensive carePharmacokinetics

• Registration Number: NL-OMON22131
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

ƒ{Age >70 years ;

ƒ{

Exclusion Criteria

ƒ{Use of CYP3A4 inhibitors or inductors at the start of the study;

oStrong to very strong CYP3A4 inhibitors: boceprevir, clarithromycin, erythromycin, grapefruit juice, indinavir, itraconazole, ketoconazole, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
-To determine the elimination half-life of midazolam in elderly patients on the ICU;<br /><br>-To determine whether accumulation of midazolam occurs in elderly patients on the ICU;<br /><br>-To determine the metabolic capacity of the liver by the ratio midazolam/1-hydroxy midazolam in elderly patients on the ICU.<br /><br>-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.<br>