Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
Overview
- Phase
- Not Applicable
- Intervention
- Piperacillin/Tazobactam Standard Dose to High Dose
- Conditions
- Obesity
- Sponsor
- Loma Linda University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Serum Maximum Concentrations for Piperacillin
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.
Investigators
Steven Forland
Clinical Pharmacy Specialist - Infectious Diseases
Loma Linda University
Eligibility Criteria
Inclusion Criteria
- •BMI greater than or equal to 30 kg/m2
- •Weight at least 105 kg
- •Age 18-89 years of age
- •Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
- •English or Spanish speaking
- •Central line access
Exclusion Criteria
- •Do not meet specified inclusion criteria
- •Hepatic impairment classified by Child-Pugh Class B or greater
- •Documented pre-existing seizure disorder
- •Documented pre-existing hematologic disorder
- •Pregnancy
- •Documented allergy or contraindication to beta-lactams or tazobactam
Arms & Interventions
Standard Dose to High Dose Piperacillin/Tazobactam
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Intervention: Piperacillin/Tazobactam Standard Dose to High Dose
Outcomes
Primary Outcomes
Serum Maximum Concentrations for Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Serum Minimum Concentrations of Piperacillin
Time Frame: 0, 1, 3, and 6 hours post-dose
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
Secondary Outcomes
- Half-life of Piperacillin(0, 1, 3, and 6 hours post-dose)
- Volume of Distribution of Piperacillin(0, 1, 3, and 6 hours post-dose)