CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Blood drawother
Likely dose
Not stated in record
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Search/NCT02306928
NCT02306928N/ACompleted

Population Pharmacokinetics of Piperacillin in the Early Phase of Septic Shock - Does Standard Dosing Result in Therapeutic Plasma Concentrations?

University of Aarhus·observational·Posted Dec 3, 2014·Updated Feb 11, 2016

In Brief

An observational study evaluating Blood draw for Septic Shock. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.6 years ago

Interventions

Blood drawother