An observational study in Respiratory Failure and Coma, sponsored by Università degli Studi dell'Insubria. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by Università degli Studi dell'Insubria · Observational
This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.
This study has three specific aims:
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Università degli Studi dell'Insubria is the lead sponsor of 67 studies on the registry; 8 are open to participants now.
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Critically ill patients in Intensive Care Unit, mechanically ventilated, sedated with midazolam, intravenous continued perfusion.
Exclusion Criteria:
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.
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.
Midazolam concentration in serum and urine
We will calculate Midazolam AUC in serum and urine using blood and urine samples. With this data we will evaluate the elimination constants and create a Physiologically Based Pharmacokinetic Model for Midazolam simulating the drug concentration profile in brain and fat tissue. The blood and urine samples timing is: * 1 blood sample will be gathered after 24h at the beginning of continuous intravenous infusion of Midazolam * 1 blood sample and 1 urine sample will be gathered after 48h at the beginning of continuous intravenous infusion of Midazolam * 1 blood sample will be gathered at the end of continuous intravenous infusion of Midazolam (the duration of infusion is different for each patient according with clinical case) * 1 blood sample and 1 urine sample will be gathered after 6h at the end of continuous intravenous infusion of Midazolam (the duration of infusion is different for each patient according with clinical case)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Fat mass analysis and its importance in drug distribution.
At enrollment we will collect data about fat mass in our population. Our goal is to determine how much this variable can modify the distribution of Midazolam in the body. Statistical analysis will performed to found if different body mass values are correlated with different blood concentration of Midazolam at steady level.
Time frame: At enrollment
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria