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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit

Conditions
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Antibiotics, Extracorporeal Membrane Oxygenation, Sepsis, Intensive Care Unit

Intervention / Treatment
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* Other: Antibiotic plasma dosage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic patient under ECMO treatment<br>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. | Other: Antibiotic plasma dosage<br>* Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Antibiotics plasma concentration (Cmin) (C min) | Dosage under steady state conditions of every antibiotics plasma concentration just before the next administration in patients with sepsis and treated by ECMO | Up to 24 hours | 
| Medium Antibiotics plasma concentration (CT 50) | 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 | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Membrane Oxygenation, Sepsis, Antibiotics, Pharmacokinetic, Intensive Care Unit