Piperacillin PK Analysis in Severe Sepsis Patients

NCT02569086 | Completed Results

• 1 other identifier: PIP/TAZO-INTERMEDIATE
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic dosing in septic patients poses a challenge for clinicians due to the pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for empirical treatment, and initial appropriate dosing is crucial for reducing mortality. The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model was be established with the dual purpose to assess current standard treatment and to simulate alternative dosing regimens and modes of administration. Time above the minimal inhibitory concentration (T\>MIC) predicted for each patient was evaluated against clinical breakpoint MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T\>MIC and 50% fT\>MIC.

Conditions

Sepsis; Severe Sepsis

Keywords

Sepsis; Therapeutic Drug Monitoring; Beta-lactams; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.

  The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.

  Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.

• 50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval.

  The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.

  Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.

Interventions

Blood draw OTHER

Eligibility Criteria

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

Study Population

Patients with severe sepsis treated empirically with Piperacillin/Tazobactam

You may qualify if:

• Treatment with Piperacillin/Tazobactam 4g/0.5g every 8 hour for less than 48 hours

You may not qualify if:

• renal replacement therapy
• Age under 18

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital, Denmark

Aarhus, Danmark, 8200, Denmark

Location

Related Publications (1)

• Andersen MG, Thorsted A, Storgaard M, Kristoffersson AN, Friberg LE, Obrink-Hansen K. Population Pharmacokinetics of Piperacillin in Sepsis Patients: Should Alternative Dosing Strategies Be Considered? Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02306-17. doi: 10.1128/AAC.02306-17. Print 2018 May.

  PMID: 29507062 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Kristina Öbrink-Hansen
• Organization: Aarhus University Hospital, Department of infectious diseases

krisoebr@rm.dk

+45

Study Officials

• Merete Storgaars, MD, PhD

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 6, 2015
• Study Start: November 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: November 13, 2017
• Results First Posted: November 13, 2017

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)