Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation (PHARMECMO)

Completed

• Conditions: Antibiotics; Intensive Care Unit; Extracorporeal Membrane Oxygenation; Sepsis
• Interventions: Other: Antibiotic plasma dosage

• Registration Number: NCT03131063
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies suggest that individualized dosing strategies and therapeutic drug monitoring could facilitate the achievement of adequate antibiotic concentration. The objective of this pilot study was to observe the pharmacokinetic characteristics of commonly used antibiotics in intensive care for patients treated with extracorporeal membrane oxygenation.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-04
• Study Completion: 2017-03
• Status Verified: 2017-04
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-04-27
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Age > 18 years
• Extra corporeal membrane oxygenation treatment
• Parenteral antibiotherapy for known or suspected sepsis
• Informed consent

Exclusion Criteria

• Refusal of participation
• Pregnancy
• Burned patient
• Steady state conditions not reached
• Non-intravenous administration of antibiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic patient under ECMO treatment	Antibiotic plasma dosage	Every adult patient admitted to ICU, under ECMO treatment, with known or suspected sepsis and receiving antibiotic therapy, was eligible for inclusion. The concentration of the studied antibiotics was determined by a combination of liquid chromatography and mass spectrometry from blood samples. For intermittent administration of antibiotic, two successive samples were performed both at 50% (Cmax) and 100% (Cmin) of the dosing interval.

Primary Outcome Measures

Name	Time	Method
Medium Antibiotics plasma concentration (CT 50)	Up to 24 hours	Dosage under steady state conditions of every antibiotic plasma concentration in the middle of the interval between two administration (CT 50) in patients with sepsis and treated by ECMO
Minimum Antibiotics plasma concentration (Cmin) (C min)	Up to 24 hours	Dosage under steady state conditions of every antibiotics plasma concentration just before the next administration in patients with sepsis and treated by ECMO