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

Overview

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.

Full Title of Study: “Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

  • Drug: 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 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

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of piperacillin in plasma
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sutep Jaruratanasirikul
  • Collaborator
    • Prince of Songkla University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sutep Jaruratanasirikul, Principal Investigator – Prince of Songkla University

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