Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

Sponsor
Karolinska University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05134298
Collaborator
(none)
50
1
50
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Piperacillin/tazobactam, Meropenem

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Study Kohort

As specified by study population, inclusion and exclusion criteria

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 17176

Sponsors and Collaborators

  • Karolinska University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johan Petersson, Senior ICU consultant, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT05134298
Other Study ID Numbers:
  • K 2018-6443
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021