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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation Sepsis Intensive Care Unit Antibiotics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic patient under ECMO treatment

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.

Antibiotic plasma dosage

Intervention Type OTHER

Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients

Interventions

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Antibiotic plasma dosage

Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Joe Elie Salem

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amour Julien, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Universitaire La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Faculté de médecine, Université Pierre et Marie Curie, Paris, INSERM U1166-ICAN, France