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

Early Phase of Severe Sepsis and Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730624
• Other study ID #: PIP-56501141
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2016
• Last updated: September 19, 2017
• Start date: March 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2016
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Early Phase of Severe Sepsis and Septic Shock
• Sepsis
• Shock
• Shock, Septic
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Sutep Jaruratanasirikul	Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 hour after the piperacillin dose