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

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ClinicalTrials.gov Identifier: NCT02730624
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
Prince of Songkla University
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

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.


Condition or disease Intervention/treatment Phase
Early Phase of Severe Sepsis and Septic Shock Drug: Piperacillin-tazobactam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis
Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730624


Locations
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Thailand
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Sutep Jaruratanasirikul
Prince of Songkla University

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Responsible Party: Sutep Jaruratanasirikul, Principal Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02730624     History of Changes
Other Study ID Numbers: PIP-56501141
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: March 2016

Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
piperacillin/tazobactam
critically ill
severe sepsis
septic shock

Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock
Critical Illness
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action