CompletedNot Applicable

Midazolam Whole Body Physiologically Based Pharmacokinetic Model

Italy20 participantsStarted 2013-01

Plain-language summary

This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ICU admittance * Caucasian * Clinical indication of least 72h of continuous sedation with Midazolam * MAP between 60 - 150 mmHg, even if obtained with amine support * informed consent obtained Exclusion Criteria: * Any endocranial lesion, spontaneous or induced * PaCO2 \> 60 mmHg or \< 30 mmHg * PaO2 \< 50 mmHg * Pregnancy * Anuria * Any transplantation * Severe hepatic failure (Child C) * Life expectancy \< 72h * Ketoconazole and antiretrovirals in therapy

What they're measuring

Midazolam concentration in serum and urine

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Trial details

NCT IDNCT01973894

SponsorUniversità degli Studi dell'Insubria

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-05

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