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

Sutep Jaruratanasirikul

Status and phase: Completed; Phase 4

Conditions: Early Phase of Severe Sepsis and Septic Shock

Treatments: Drug: Piperacillin-tazobactam

Study type: Interventional

Funder types: Other

Identifiers

NCT02730624

PIP-56501141

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

piperacillin/tazobactam

Experimental group

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

Treatment:

Drug: Piperacillin-tazobactam