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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03131063
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
Joe Elie Salem, 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.

Condition or disease Intervention/treatment
Extracorporeal Membrane Oxygenation Sepsis Intensive Care Unit Antibiotics Other: Antibiotic plasma dosage

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit
Actual Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Group/Cohort Intervention/treatment
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.
Other: Antibiotic plasma dosage
Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients

Primary Outcome Measures :
  1. Minimum Antibiotics plasma concentration (Cmin) (C min) [ Time Frame: 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

  2. Medium Antibiotics plasma concentration (CT 50) [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were selected from patients hospitalized in cardiac surgical intensive care units with clinico-biological elements in favor of sepsis and for whom antibiotic therapy was instituted. An ECMO treatment before study enrollement was required.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03131063

Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
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Study Director: Amour Julien, MD, PhD Hôpital Universitaire La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Faculté de médecine, Université Pierre et Marie Curie, Paris, INSERM U1166-ICAN, France

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Responsible Party: Joe Elie Salem, MD, PhD, Groupe Hospitalier Pitie-Salpetriere Identifier: NCT03131063     History of Changes
Other Study ID Numbers: ID RCB : 2014-A00043-44
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
Extracorporeal Membrane Oxygenation
Intensive Care Unit

Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents