Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine
Goal of study:
To assess the tissular and plasma kinetics of ertapenem;
To determine the optimal dosages in the patients according to norepinephrine administration:
- to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
- to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.
Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).
|To Assess the Tissular and Plasma Kinetics of Ertapenem||Drug: Ertapenem||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- assess the tissular and plasma kinetics of ertapenem [ Time Frame: 24 months ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
1g a day by drip of 30 min
No Intervention: 2
No adrenalin infusion
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489138
|Département d'Anesthésie-Réanimation - CHU NORD|
|Marseille, France, 13915|
|Principal Investigator:||Ioanna BOYADJIEV, PH||Assistance Publique Hôpitaux de Marseille|