Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Terminated

• Conditions: Drug Effect
• Interventions: Drug: piperacillin-tazobactam; Drug: Cefazolin

• Registration Number: NCT03922451
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Study Start: 2019-08-27
• Primary Completion: 2020-04-01
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• supported on ECMO
• receive piperacillin-tazobactam or cefazolin as part of routine care or infection management

Exclusion Criteria

• >= 18 years
• No Consent provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients supported on ECMO	piperacillin-tazobactam	-
Pediatric patients supported on ECMO	Cefazolin	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration: cefazolin	Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.	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.
Plasma concentration: piperacillin-tazobactam	Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States