NCT01973894

Midazolam Whole Body Physiologically Based Pharmacokinetic Model

Whole Body Physiologically Based Pharmacokinetic (PBPK) Model to Estimate Cerebral and Systemic Midazolam Concentrations in ICU Patients Under Sedation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study has three specific aims: 1. to create a Midazolam PBPK model based on anthropometric and physiopathological data from enrolled patients; 2. to estimate cerebral and systemic Midazolam concentrations; 3. to assess independent variables about Midazolam pharmacokinetic in critically ill patients.

Conditions

• Respiratory Failure
• Coma

Interventions

Type	Name	Description
PROCEDURE	Blood and urine sampling	Blood and urine sampling will follow this schedule: * 24h: blood (3ml) * 48h: blood (3ml) and urine * End of infusion: blood (3ml) * 6h after end of infusion: blood (3ml) and urine. Blood samples will be centrifuged for 10 minutes at 3300rpm, then supernatant will be placed into test tubes and stored at -20°C; urine samples will be freeze at -20°C as well. Then all frozen samples will be analyzed to get Midazolam concentrations.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-11-01
• Last updated: 2017-05-25

Locations

1 site across 1 country: Italy