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

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03131063

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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	Phase
Extracorporeal Membrane Oxygenation Sepsis Intensive Care Unit Antibiotics	Other: Antibiotic plasma dosage

Study Design

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 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Investigators

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