Towards dose optimisation through pharcokinetic profiling of piperacillin/tazobactam in critically ill patients

Phase 4

Completed

• Conditions: effect; infection; 10004018

• Registration Number: NL-OMON39910
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Adult >= 18 yrs
Admiited to the ICU
Proven or suspected infection
Indication for treatment with Piperacillin-tazobactam

Exclusion Criteria

Pregnancy
Severe anemia
Contraindication for Piperacillin-tazobactam, including known or suspected allergy
Contraindication for continuous infusion

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total bound plasma concentrations of piperacillin (and unbound plasma<br /><br>concentrations of piperacillin as well as tazobactam plasma concentrations when<br /><br>feasible in our laboratory); PK parameters; APACHE II; target attainment at<br /><br>different time intervals based on predefined microbiological targets based on<br /><br>MICs of specific micro-organisms; microbiological outcome; clinical outcome</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessment of relationship between PK parameters and APACHE II score<br /><br>- To evaluate outcome in terms of ICU-mortality; mortality at day 28 after<br /><br>inclusion; cause of death; microbiological success (eradication of<br /><br>P/T-susceptible micro-organism) or failure (development of P/T-resistance in<br /><br>previously susceptible micro-organism)<br /><br>- Assessment of reliability of determination of free fraction of P/T from the<br /><br>bound fraction and routinely collected parameters (e.g. serum albumin) - when<br /><br>tazobactam concentration measurements are available.<br /><br>- Determination of P/T ratio change in organ failure -when tazobactam<br /><br>concentration measurements are available. </p><br>