Midazolam Whole Body Physiologically Based Pharmacokinetic Model

NCT01973894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2017-05-25

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER
  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Paolo Severgnini, Prof. · Università degli Studi dell'Insubria, Varese, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973894 on ClinicalTrials.gov