Extracorporeal Membrane OxygenationPHARMECMONCT03131063
Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation (PHARMECMO)
An observational study of Extracorporeal Membrane Oxygenation and Sepsis, run by Groupe Hospitalier Pitie-Salpetriere.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Sepsis, Intensive Care Unit
- What is being tested?
- Antibiotic plasma dosage
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were selected from patients hospitalized in cardiac surgical intensive care units with clinico-biological elements in favor of sepsis and for whom antibiotic therapy was instituted. An ECMO treatment before study enrollement was required.
Who may be able to join
- Age > 18 years
- Extra corporeal membrane oxygenation treatment
- Parenteral antibiotherapy for known or suspected sepsis
- Informed consent
Who cannot join
- Refusal of participation
- Pregnancy
- Burned patient
- Steady state conditions not reached
- Non-intravenous administration of antibiotherapy
About this study
Official title: A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit
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.
- Being tested
- Antibiotic plasma dosage
- Keywords
- Extracorporeal Membrane Oxygenation, Sepsis, Antibiotics, Pharmacokinetic, Intensive Care Unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic plasma dosageOther
Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Antibiotic plasma dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 hours
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
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startMay 2014
- Primary completionApr 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Amour Julien, MD, PhD, Study director, Hôpital Universitaire La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Faculté de médecine, Université Pierre et Marie Curie, Paris, INSERM U1166-ICAN, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131063
- Sponsor's protocol ID
- ID RCB : 2014-A00043-44
- Acronym
- PHARMECMO
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03131063
- Acronym / sponsor ID
- PHARMECMO / ID RCB : 2014-A00043-44
- Keywords
- Extracorporeal Membrane Oxygenation, Sepsis, Antibiotics, Pharmacokinetic, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic patient under ECMO treatment | – | Other: Antibiotic plasma dosageEvery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected from patients hospitalized in cardiac surgical intensive care units with clinico-biological elements in favor of sepsis and for whom antibiotic therapy was instituted. An ECMO treatment before study enrollement was required.
Key inclusion criteria (4 listed)
- Age > 18 years
- Extra corporeal membrane oxygenation treatment
- Parenteral antibiotherapy for known or suspected sepsis
- Informed consent
Key exclusion criteria (5 listed)
- Refusal of participation
- Pregnancy
- Burned patient
- Steady state conditions not reached
- Non-intravenous administration of antibiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic plasma dosageMeasurement of the concentration of antibiotics administered as part of the routine care of intensive care patients | Other | Septic patient under ECMO treatment |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amour Julien, MD, PhD study director
Hôpital Universitaire La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Faculté de médecine, Université Pierre et Marie Curie, Paris, INSERM U1166-ICAN, France
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Sepsis, run by Groupe Hospitalier Pitie-Salpetriere.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Antibiotics plasma concentration (Cmin) (C min) (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.