Extracorporeal Membrane OxygenationNCT03766282
Pharmacokinetics in Extracorporeal Membrane Oxygenation
An observational study of Extracorporeal Membrane Oxygenation and Pharmacokinetics, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Pharmacokinetics
- What is being tested?
- ECMO
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Dec 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing ECMO
Who may be able to join
- Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
- Clinical indication for the antibiotics
- Clinical indication for the sedatives and analgesics
Who cannot join
- No consent
- Known allergy to study drug
- Pregnancy
- Massive fluid resuscitation (>50% blood volume transfused) in the previous 8 hours.
- Therapeutic plasma exchange in the preceding 24 hours
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100028
Chen Wang, MD
About this study
Official title: Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.
Read the detailed description
Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.
- Being tested
- ECMO
- Keywords
- Pharmacokinetics, extracorporeal membrane oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
Also called Extracorporeal membrane oxygenation
Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| Animal study | Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO. Receives: Device: ECMO | |
| Clinical study | To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients. Receives: Device: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median observed peak concentration(Cmax)
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Measured: one-dose period
The median observed through concentration(Cmin)
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Measured: one-dose period
Volume of distribution(Vd)
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Measured: one-dose period
Area under the plasma concentration versus time curve (AUC)
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Measured: one-dose period
Inter-compartmental clearance (Q)
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Measured: one-dose period
Clearance(CL)
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Measured: one-dose period
Secondary outcomes (1)
Development of strategies for drug administration in critically ill patients receiving ECMO
PK models for study drugs using a non-linear mixed effects modeling approach.
Measured: one-dose period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Sep 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingyuan Zhan, China-Japan Friendship Hospital
- Investigators
- Chen Wang, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766282
- Sponsor's protocol ID
- 2017-2-QN-15
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20.
PubMed 32816724
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03766282
- Acronym / sponsor ID
- 2017-2-QN-15
- Keywords
- Pharmacokinetics, extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 6 Dec 2018 (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 main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.
Detailed description
Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal study | – | Device: ECMOCritically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO. |
| Clinical study | – | Device: ECMOTo describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing ECMO
Key inclusion criteria (3 listed)
- Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
- Clinical indication for the antibiotics
- Clinical indication for the sedatives and analgesics
Key exclusion criteria (5 listed)
- No consent
- Known allergy to study drug
- Pregnancy
- Massive fluid resuscitation (>50% blood volume transfused) in the previous 8 hours.
- Therapeutic plasma exchange in the preceding 24 hours
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 |
|---|---|---|
| ECMOAlso: Extracorporeal membrane oxygenationExtracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure | Device | Animal study, Clinical study |
Primary outcome
The median observed peak concentration(Cmax)
Time frame: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
The median observed through concentration(Cmin)
Time frame: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Volume of distribution(Vd)
Time frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Area under the plasma concentration versus time curve (AUC)
Time frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Inter-compartmental clearance (Q)
Time frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Clearance(CL)
Time frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
1 secondary outcome
Development of strategies for drug administration in critically ill patients receiving ECMO
Time frame: one-dose period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Derived from this study: PubMed 32816724Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20.
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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.
Chen Wang study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Pharmacokinetics, run by China-Japan Friendship Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingyuan Zhan, MD (13683598417, zhanqy0915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median observed peak concentration(Cmax) (time frame: one-dose period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766282, which also lists 1 linked publication.
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 6 Dec 2018.