Drug EffectNCT03787550
PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO
An observational study of Drug Effect, run by Guangdong Provincial People's Hospital at 3 sites in China.
Trial summary
It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- The Sedatives, analgesics and antibiotics
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- 7 Feb 2020to 31 Mar 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external validation for each drug. The investigators plan to study the sedatives, analgesics and antibiotics with the initial sample size at 36 in total.
Who may be able to join
- Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
- Age from 18 to 85 years old.
- Multiple blood sampling is acceptable.
Who cannot join
- Patients who are allergic to the investigated drugs.
- Patients who are pregnant.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Chunbo Chen, Ph.D.
Xipei Wang, Ph.D., xipei_wang@163.com
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
About this study
Official title: Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.
- Conditions
- Drug Effect
- Being tested
- The Sedatives, analgesics and antibiotics
- Keywords
- ECMO, Sedatives, Analgesics, Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Sedatives, analgesics and antibioticsDrug
The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.
| Study group | Role | What they receive |
|---|---|---|
| Model building group | The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. Receives: Drug: The Sedatives, analgesics and antibiotics | |
| Model validation group | The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. Receives: Drug: The Sedatives, analgesics and antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Plasma Concentration [Cmin]
The minimum plasma concentration (the trough concentration), usually collected before the next dose.
Measured: Up to 24 hours.
Area Under the Curve [AUC]
The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.
Measured: Up to 24 hours.
Maximum Plasma Concentration [Cmax]
The maximum plasma concentration, usually at the end of the infusion during an dose interval.
Measured: Up to 24 hours.
Secondary outcomes (4)
ICU mortality
The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage.
Measured: Up to 60 days.
Hospital mortality
The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage.
Measured: Up to 60 days.
Mechanical ventilation duration
Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.
Measured: Up to 60 days.
ICU length of stay (LOS)
ICU length of stay (LOS) is the length of days the patients in the ICU.
Measured: Up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start7 Feb 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunbo Chen, Ph. D., Study chair, Guandong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787550
- Sponsor's protocol ID
- ECMO001
- Status last verified
- May 2019
- First submitted
- 21 Nov 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT03787550
- Acronym / sponsor ID
- ECMO001
- Conditions
- Drug Effect
- Keywords
- ECMO, Sedatives, Analgesics, Antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 7 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 26 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.
It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model building group | – | Drug: The Sedatives, analgesics and antibioticsThe data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. |
| Model validation group | – | Drug: The Sedatives, analgesics and antibioticsThe data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external validation for each drug. The investigators plan to study the sedatives, analgesics and antibiotics with the initial sample size at 36 in total.
Key inclusion criteria (3 listed)
- Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
- Age from 18 to 85 years old.
- Multiple blood sampling is acceptable.
Key exclusion criteria (2 listed)
- Patients who are allergic to the investigated drugs.
- Patients who are pregnant.
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 |
|---|---|---|
| The Sedatives, analgesics and antibioticsThe sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need. | Drug | Model building group, Model validation group |
Primary outcome
Minimum Plasma Concentration [Cmin]
Time frame: Up to 24 hours.
The minimum plasma concentration (the trough concentration), usually collected before the next dose.
Area Under the Curve [AUC]
Time frame: Up to 24 hours.
The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.
Maximum Plasma Concentration [Cmax]
Time frame: Up to 24 hours.
The maximum plasma concentration, usually at the end of the infusion during an dose interval.
4 secondary outcomes
ICU mortality
Time frame: Up to 60 days.
Hospital mortality
Time frame: Up to 60 days.
Mechanical ventilation duration
Time frame: Up to 60 days.
ICU length of stay (LOS)
Time frame: Up to 60 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Chunbo Chen, Ph. D. study chair
Guandong General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Effect, run by Guangdong Provincial People's Hospital at 3 sites 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 2 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Chunbo Chen, Ph. D. (+86-20-83827812 ext. 51157, gghccm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Plasma Concentration [Cmin] (time frame: Up to 24 hours.). The study lists 3 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 17 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.