N/A
N=15
PK Analysis of Piperacillin in Septic Shock Patients
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT02306928 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Jun 2015
Primary outcome: Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 10 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
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. |
10 | — |
| PRIMARY 50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval. |
12 | — |
| SECONDARY The Maximum Concentration of Piperacillin (Cmax) |
546 | — |
| SECONDARY The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8) |
1148 | — |
| SECONDARY Trough Piperacillin Plasma Concentration (Cmin) |
51.7 | — |
Summary
Antibiotic dosing in septic shock 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.
We determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 15 patients treated empirically for septic shock. A PK population model was 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 were 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>4xMIC.
Eligibility Criteria
Inclusion Criteria
Treatment with piperacillin/tazobactam for less than 24 hours. Treatment with noradrenaline. -
Exclusion Criteria
Renal replacement therapy. Age under 18.
-
Data sourced from ClinicalTrials.gov (NCT02306928). 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.