Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Verification of the ECMO-induced changes of colistin or CMS area under the plasma concentration versus time curve (AUC) in critically ill patients. |
The primary objective of the clinical trial is to determine the area under the plasma concentration versus time curve of colistin and CMS in critically ill patients with and without ECMO during the dosing interval, calculate and compare the area under the plasma concentration versus time curve of CMS and colistin in each group. |
24 hours |
|
Secondary |
Model of population pharmacokinetics of colistin in critically ill patients - Cmax |
To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The first one is maximum plasma concentrations [Cmax] that will be obtain 2 hours after colistin administration. |
2 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
|
Secondary |
Model of population pharmacokinetics of colistin in critically ill patients - Tmaxc |
To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The second one is time to maximum plasma concentration (Tmaxc) that will be calculated within 2 hours after colistin administration. |
2 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
|
Secondary |
Model of population pharmacokinetics of colistin in critically ill patients - Tminc |
To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The third one is time to minimum plasma concentration (Tminc) that will be calculated within 12 hours after colistin administration. |
12 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
|
Secondary |
Model of population pharmacokinetics of colistin in critically ill patients - Cmin |
To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The fourth one is minimum plasma concentration (Cmin) that will be calculated within 12 hours after colistin administration. |
12 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
|
Secondary |
Model of population pharmacokinetics of colistin in critically ill patients - AUC |
To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The fifth one is Area Under the Curve (AUC) that will be calculated within 24 hours after colistin administration. |
24 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
|