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NCT03131063 Clinical Trial

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

Sepsis Clinical Trial

— PHARMECMO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03131063
Other study ID # ID RCB : 2014-A00043-44
Secondary ID
Status Completed
Phase N/A
First received April 21, 2017
Last updated April 26, 2017
Start date May 2014
Est. completion date March 2017

Study information
Verified date April 2017
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date March 2017
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Antibiotic plasma dosage
Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Outcome
Type Measure Description Time frame Safety issue
Primary Minimum Antibiotics plasma concentration (Cmin) (C min) Dosage under steady state conditions of every antibiotics plasma concentration just before the next administration in patients with sepsis and treated by ECMO Up to 24 hours
Primary Medium Antibiotics plasma concentration (CT 50) 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 Up to 24 hours
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