Back to resultsPiperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock
Primary Purpose
Early Phase of Severe Sepsis and Septic Shock
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Piperacillin-tazobactam
Sponsored by
About this trial
This is an interventional treatment trial for Early Phase of Severe Sepsis and Septic Shock focused on measuring piperacillin/tazobactam, critically ill, severe sepsis, septic shock
Eligibility 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
Sites / Locations
- Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
piperacillin/tazobactam
Arm Description
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
Outcomes
Primary Outcome Measures
Concentration of piperacillin in plasma
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02730624
First Posted
February 24, 2016
Last Updated
September 19, 2017
Sponsor
Sutep Jaruratanasirikul
Collaborators
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT02730624
Brief Title
Piperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock
Official Title
Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sutep Jaruratanasirikul
Collaborators
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Phase of Severe Sepsis and Septic Shock
Keywords
piperacillin/tazobactam, critically ill, severe sepsis, septic shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
piperacillin/tazobactam
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Piperacillin-tazobactam
Intervention Description
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 Measure Information:
Title
Concentration of piperacillin in plasma
Description
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.
Time Frame
6 hour after the piperacillin dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Piperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock
We'll reach out to this number within 24 hrs