N/A
N=22
Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT02569086 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Nov 2017
Primary outcome: Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood draw (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Aarhus
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. |
4 | — |
| PRIMARY 50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval. |
15 | — |
Summary
Antibiotic dosing in septic patients poses a challenge for clinicians due to the pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for empirical treatment, and initial appropriate dosing is crucial for reducing mortality.
The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model was be established with the dual purpose to assess current standard treatment and to simulate alternative dosing regimens and modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted for each patient was evaluated against clinical breakpoint MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and 50% fT>MIC.
Eligibility Criteria
Inclusion Criteria
- Treatment with Piperacillin/Tazobactam 4g/0.5g every 8 hour for less than 48 hours
Exclusion Criteria
- renal replacement therapy
- Age under 18
Data sourced from ClinicalTrials.gov (NCT02569086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.