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
Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: To Assess the Tissular and Plasma Kinetics of Ertapenem
Intervention: Ertapenem (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Assistance Publique Hopitaux De Marseille Official(s) and/or principal investigator(s):
Ioanna BOYADJIEV, PH, Principal Investigator, Affiliation: Assistance Publique Hôpitaux de Marseille
Summary
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).
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: assess the tissular and plasma kinetics of ertapenem
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years and more
- negative pregnancy test
- HIV/HBV, HCV negative tests
- Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
Exclusion Criteria:
- refractory septic shock requiring use of additional catecholamines
- patients with positives tests for HIV, HBV, HCV
- pregnant females
- allergic insufficiency
- hemodiafiltration
- contraindication to microdialysis catheter set-up
- severe arteritis of lower extremities
- treatment with vasodilatators
- prior history of aorto-iliac shunt
- involvement in a clinical trial in the last three months
- exclusion from national records
- non affiliated to "securité sociale"
Locations and Contacts
Département d'Anesthésie-Réanimation - CHU NORD, Marseille 13915, France
Additional Information
Starting date: April 2007
Last updated: February 24, 2014
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