ClinicalTrials.Veeva

Menu

Midazolam Whole Body Physiologically Based Pharmacokinetic Model (MidPBPK)

U

Università degli Studi dell'Insubria

Status

Completed

Conditions

Coma
Respiratory Failure

Treatments

Procedure: Blood and urine sampling

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Midazolam
Description:
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.
Treatment:
Procedure: Blood and urine sampling

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems