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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Terminated; Phase 4

Conditions: To Assess the Tissular and Plasma Kinetics of Ertapenem

Treatments: Drug: Ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT00489138

2006/24

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

1

Experimental group

Description:

Noradrenalin infusion

Treatment:

Drug: Ertapenem

2

No Intervention group

Description:

No adrenalin infusion