Objective: The primary objective of this study is to evaluate the pharmacokinetics of midazolam in elderly patients (>70 years) admitted to the ICU.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Situaties waarbij sedatie op de IC nodig is
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The pharmacokinetic profile of midazolam in
elderly patients on the ICU.
Secondary outcome
- 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.
Background summary
Rationale: Patients on the Intensive Care Unit (ICU) are often sedated to
reduce anxiety and facilitate treatment.eg mechanical ventilation. Midazolam
is frequently used as a sedative. Physiologic changes by both aging and
critical illness might have their consequences for the pharmacokinetics of
midazolam. Both in patients on the ICU and in the elderly, it has been observed
that the elimination half-life could be prolonged. To our knowledge no studies
are currently available describing the effect of aging on the pharmacokinetics
of midazolam, while the percentage elderly patients on the ICU is increasing.
Hypothetically, the elimination half-life of midazolam in elderly intensive
care patients is double prolonged. In order to optimize sedation adequate
dosing administration is required
Study objective
Objective: The primary objective of this study is to evaluate the
pharmacokinetics of midazolam in elderly patients (>70 years) admitted to the
ICU.
Study design
Study design: Prospective pilot study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: In this study, at least 11 blood samples will
be taken in order to determine midazolam levels. The midazolam level will not
be used to adjust the dose during the study period and standard care will be
provided (determination of bloodlevels will be performed at the end of the
study period). The difference between standard treatment and participation in
this study consists of collection of at least 11 additional blood samples.
Because intensive care patients have an indwelling arterial catheter, this will
be of minimal discomfort for the patient.
Van Swietenplein 1 1
Groningen 9728NT
NL
Van Swietenplein 1 1
Groningen 9728NT
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65812.099.18 |