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Completed

NCT Number: NCT03131063

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

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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Key information

Conditions

Extracorporeal Membrane Oxygenation Antibiotics Infections Inflammation Intensive Care Unit Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic plasma dosage

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

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

Acronym: PHARMECMO

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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