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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03131063

Acronym

PHARMECMO

Enrollment

Registered

2017-04-27

Start date

2014-05-31

Completion date

2017-03-31

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics, Extracorporeal Membrane Oxygenation, Intensive Care Unit, Sepsis

Keywords

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

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.

Interventions

OTHERAntibiotic plasma dosage

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026