Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

• Conditions: Antibiotic Pharmacokinetics
• Interventions: Drug: Piperacillin/tazobactam, Meropenem

• Registration Number: NCT05134298
• Lead Sponsor: Karolinska University Hospital

Brief Summary

The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Study Start: 2019-11-01
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.

Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):

• Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
• Not posisble to obtain and process blood samples as specified by protocol.
• Ongoing renal replacement therapy.
• Patient having received the same antibiotic within the previous 96 h.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Kohort	Piperacillin/tazobactam, Meropenem	As specified by study population, inclusion and exclusion criteria

Primary Outcome Measures

Name	Time	Method
Plasma clearance	For the first antibiotic administration and if possible for a second administration 48-72 hour later.	Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
Volume of distribution	For the first antibiotic administration and if possible for a second administration 48-72 hour later.	Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.

Secondary Outcome Measures

Name	Time	Method
Plasma antibiotic concentrations at mid and end of dosing interval	For the first antibiotic administration and if possible for a second administration 48-72 hour later.	Plasma antibiotic concentrations at mid and end of dosing interval

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden