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Piperacillin PK Analysis in Severe Sepsis Patients

NCT02569086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2017-11-13

Study results available
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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.

Conditions

Interventions

OTHER

Blood draw

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT02569086 on ClinicalTrials.gov