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

Phase 4

Terminated

• Conditions: To Assess the Tissular and Plasma Kinetics of Ertapenem
• Interventions: Drug: Ertapenem

• Registration Number: NCT00489138
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ertapenem	Noradrenalin infusion

Primary Outcome Measures

Name	Time	Method
assess the tissular and plasma kinetics of ertapenem	24 months

Trial Locations

Locations (1)

Département d'Anesthésie-Réanimation - CHU NORD; 🇫🇷 Marseille, France