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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39910

Enrollment

Registered

2013-06-07

Start date

2013-12-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

effect infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results