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

NCT ID: NCT02730624

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-01-31

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.

Conditions

Early Phase of Severe Sepsis and Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Piperacillin-tazobactam

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: collaborator

Sutep Jaruratanasirikul

OTHER

Sponsor Role: lead

Responsible Party

Sutep Jaruratanasirikul

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

PIP-56501141

Identifier Type: -

Identifier Source: org_study_id