Piperacillin Pharmacokinetics in ICU Patients

NCT02478073 | Unknown

• 1 other identifier: AB-ICU
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic dosing in critically ill 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. Patients in the Intensive Care Unit (ICU), treated with piperacillin/tazobactam, had their plasma concentration of piperacillin determined 1-3 times weekly. Patients received piperacillin as intermittent bolus infusion 3 times daily or as continuous infusion (this was up to the treating physician). Time above the minimal inhibitory concentration (T\>MIC) estimated 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 (free piperacillin concentration maintained above the MIC throughout the dosing interval) and 50% fT\>4xMIC (free piperacillin concentration maintained at a level fourfold the MIC for at least 50% of the dosing interval).

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Blood-plasma concentration of Piperacillin

  Blood-plasma concentration of Piperacillin will be performed through ultra high performance liquid chromatography (UPLC). The concentrations will be compared to the clinical breakpoint MIC for Pseudomonas aeruginosa (16 mg/L).

  A blood-test will be drawn 1-3 times weekly. Participants will be followed for the duration of piperacillin/tazobactam treatment, an expected average time of two weeks.

Secondary Outcomes (1)

• Percentage of time above the minimal inhibitory concentration (T>MIC)

  A blood-test will be drawn 1-3 times weekly. Participants will be followed for the duration of piperacillin/tazobactam treatment, an expected average time of two weeks.

Eligibility Criteria

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

Study Population

Critically ill patients with sepsis or septic shock, treated with piperacillin/tazobactam in the Intensive Care Unit (ICU).

You may qualify if:

• Sepsis or septic shock
• Treatment with piperacillin/tazobactam

You may not qualify if:

• Age under 18 years
• Renal replacement therapy

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus Univbersity Hospital, Department of Anesthesia and Intensive Care Medicine

Aarhus N, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jakob Gjedsted, MD, PhD

  Aarhus University Hospital, Department of Anesthesia and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Öbrink-Hansen, MD

CONTACT

+45 78452845; krisoebr@rm.dk

Jakob Gjedsted, MD, PhD

CONTACT

+45 7845 1030; jakob.gjedsted@auh.rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

DK (1)