Early Phase of Severe Sepsis and Septic Shock Clinical Trial
Official title:
Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis
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.
n/a