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

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Antibiotics; Intensive Care Unit; Extracorporeal Membrane Oxygenation; Sepsis

Treatments: Other: Antibiotic plasma dosage

Study type: Observational

Funder types: Other

Identifiers

NCT03131063

ID RCB : 2014-A00043-44

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

45 participants in 1 patient group

Septic patient under ECMO treatment

Description:

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.

Treatment:

Other: Antibiotic plasma dosage