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

Withdrawn

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

Registration Number: NL-OMON45744

Lead Sponsor: Intensive Care

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The pharmacokinetic profile of midazolam in<br /><br>elderly patients on the ICU.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the elimination half-life of midazolam in elderly patients on<br /><br>the ICU;<br /><br>- To determine whether accumulation of midazolam occurs in elderly patients on<br /><br>the ICU;<br /><br>- To determine the metabolic capacity of the liver by the ratio<br /><br>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<br /><br>such as: ldecreased kidney function, inflammatory state, cardiac function and<br /><br>body mass on the pharmacokinetic profile of midazolam.</p><br>