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PK Analysis of Piperacillin in Septic Shock Patients

NCT02306928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2016-02-11

Study results available
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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.

Conditions

  • Septic Shock

Interventions

OTHER

Blood draw

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Merete Storgaard, MD · Department of Infectious Diseases, Aarhus University Hospital, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306928 on ClinicalTrials.gov