Pediatric Patients Receiving Venoarterial Extracorporeal Membrane OxygenationNCT04701099
Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation
An observational study of Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation, run by Yonsei University at 1 site in South Korea.
Trial summary
Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2020to Apr 2023
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under the age of 19 who are receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl while using VA ECMO in Severance Hospital, Yonsei University Health System.
Who may be able to join
- <19 years old
- receiving VA ECMO in Severance Hospital, Yonsei University Health System.
- receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
- agreed to participate
Who cannot join
- receiving drugs that could affect study drug's concentration due to drug-drug interaction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System
Seoul
Yu Rim Shin, Assistant Professor, 82-2-2228-8480, yull0629@yuhs.ac
About this study
Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| On ECMO | patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl during ECMO support. | |
| Off ECMO | patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl after weaning off ECMO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum or plasma concentration
Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 during ECMO
Serum or plasma concentration
Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 after weaning off ECMO
Pharmacokinetic parameter: Volume of distribution
Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 during ECMO
Pharmacokinetic parameter: Volume of distribution
Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 after weaning off ECMO
Pharmacokinetic parameter: Clearance
Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 during ECMO
Pharmacokinetic parameter: Clearance
Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Measured: Between day0 to day3 after weaning off ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start7 Jun 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Receiving Venoarterial Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Rim Shin, Assistant Professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701099
- Sponsor's protocol ID
- 4-2020-0182
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04701099
- Acronym / sponsor ID
- 4-2020-0182
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 8 Jan 2021 (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.
Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On ECMO | – | –patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl during ECMO support. |
| Off ECMO | – | –patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl after weaning off ECMO. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under the age of 19 who are receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl while using VA ECMO in Severance Hospital, Yonsei University Health System.
Key inclusion criteria (4 listed)
- <19 years old
- receiving VA ECMO in Severance Hospital, Yonsei University Health System.
- receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
- agreed to participate
Key exclusion criteria (1 listed)
- receiving drugs that could affect study drug's concentration due to drug-drug interaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum or plasma concentration
Time frame: Between day0 to day3 during ECMO
Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Serum or plasma concentration
Time frame: Between day0 to day3 after weaning off ECMO
Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Volume of distribution
Time frame: Between day0 to day3 during ECMO
Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Volume of distribution
Time frame: Between day0 to day3 after weaning off ECMO
Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Clearance
Time frame: Between day0 to day3 during ECMO
Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Clearance
Time frame: Between day0 to day3 after weaning off ECMO
Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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.
Yu Rim Shin, Assistant Professor principal investigator
Severance 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 Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation, run by Yonsei University at 1 site in South Korea.
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 1 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 8 Jan 2021. 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 South Korea. 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 Yu Rim Shin, Assistant Professor (82-2-2228-8480, yull0629@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum or plasma concentration (time frame: Between day0 to day3 during ECMO). 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?
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 8 Jan 2021.