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

Phase 4

Completed

• Conditions: Early Phase of Severe Sepsis and Septic Shock
• Interventions: Drug: Piperacillin-tazobactam

• Registration Number: NCT02730624
• Lead Sponsor: Sutep Jaruratanasirikul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-02-24
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2016-05
• Study Completion: 2017-01
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
piperacillin/tazobactam	Piperacillin-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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand