Midazolam Whole Body Physiologically Based Pharmacokinetic Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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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

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Respiratory Failure Coma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Midazolam

Patients will be enrolled within 24h from the beginning of continuous Midazolam perfusion.

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.

Blood and urine sampling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No