Study Stopped
COVID-19 - study and recruitment not feasible
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
1 other identifier
observational
4
1 country
1
Brief Summary
This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedStudy Start
First participant enrolled
August 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedMarch 21, 2022
March 1, 2022
7 months
April 15, 2019
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma concentration: piperacillin-tazobactam
Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.
Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Plasma concentration: cefazolin
Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.
Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Study Arms (1)
Pediatric patients supported on ECMO
Interventions
Administered for infection treatment or prophylaxis per hospital protocol
Administered for infection treatment or prophylaxis per hospital protocol
Eligibility Criteria
All pediatric patients who are supported on ECMO at Boston Children's Hospital Cardiac Intensive Care Unit (CICU) and receive piperacillin-tazobactam or cefazolin as part of routine care or infection management.
You may qualify if:
- supported on ECMO
- receive piperacillin-tazobactam or cefazolin as part of routine care or infection management
You may not qualify if:
- \>= 18 years
- No Consent provided
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiac Intensivist
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 22, 2019
Study Start
August 27, 2019
Primary Completion
April 1, 2020
Study Completion
February 28, 2022
Last Updated
March 21, 2022
Record last verified: 2022-03