Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

Overview

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.

Full Title of Study: “First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Drug: Piperacillin/tazobactam, Meropenem
    • This is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration.

Arms, Groups and Cohorts

  • Study Kohort
    • As specified by study population, inclusion and exclusion criteria

Clinical Trial Outcome Measures

Primary Measures

  • Volume of distribution
    • Time Frame: 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.
  • Plasma clearance
    • Time Frame: 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.

Secondary Measures

  • Plasma antibiotic concentrations at mid and end of dosing interval
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Johan Petersson, Senior ICU consultant, Associate Professor – Karolinska University Hospital
  • Overall Contact(s)
    • Johan Petersson, MD, Ass Prof, +46-8-51770000, johan.petersson@sll.se

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