drugset / Trial / NCT02730624

Piperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock

NCT02730624

NaSingle-groupOpen-labelTreatment

Summary

This is prospective study to assess the pharmacodynamics (t\>MIC) of 4.5 g every 6 h of piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following administration by a 30 min infusion. Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE II score, BUN, Cr and fluid balance will be collected. Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be carried out during the piperacillin/tazobactam therapy. Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy. Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get PK/PD index and reported to % PTA and % CFR.

Timeline

Start
2014-03
Primary completion
2016-05
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Piperacillin Small molecule
Background Tazobactam Small molecule