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

NCT02730624 | Completed Phase 4

• 1 other identifier: PIP-56501141
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

piperacillin/tazobactam; critically ill; severe sepsis; septic shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

piperacillin/tazobactam

EXPERIMENTAL

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

Interventions

Piperacillin-tazobactam 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

piperacillin/tazobactam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutep Jaruratanasirikul: lead
• Prince of Songkla University: collaborator

Study Sites (1)

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Shock, Septic; Critical Illness; Sepsis

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2016-03

Locations

TH (1)