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

Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02730624

Enrollment

Registered

2016-04-06

Start date

2014-03-31

Completion date

2017-01-31

Last updated

2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Phase of Severe Sepsis and Septic Shock

Keywords

piperacillin/tazobactam, critically ill, severe sepsis, septic shock

Brief 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.

Interventions

DRUGPiperacillin-tazobactam

4.5 g of piperacillin/tazobactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 30 min every 6 h and blood sample were obtained by direct venepuncture at 0, 0-0.5, 0.5-2, 2-4 and 4-6 hour after drug administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* sepsis patient (defined by 2011 SCCM/ESICM/ACCP/ATS/SIS International sepsis definition conference) * severe sepsis or septic sock was defined by * Severe sepsis (sepsis with organ dysfunction) * Septic shock (sepsis with systolic arterial pressure\<90 mmHg, mean arterial pressure\<60 mmHg or decrease systolic blood pressure\> 40 mmHg from base line)

Exclusion criteria

* Patients who are pregnant. * Patients who have documented hypersensitivity to beta-lactam * Patients who are dialysis * Patients who are severe sepsis or septic shock more than 24 hour

Design outcomes

Primary

Measure	Time frame	Description
Concentration of piperacillin in plasma	6 hour after the piperacillin dose	Concentration of piperacillin in plasma will be simulated in Monte Carlo simulation to assess PK/PD index as 40% and 100% T\>MIC and will be reported as %PTA.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026