Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Study Overview
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Brief Summary
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Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Detailed Description
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Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.

Official Title
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Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Drug: ertapenem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized in ICU Receiving Continuous hemodialysis Prescribed ertapenem Informed consent granted Exclusion Criteria: < 18 years of age Allergy to ertapenem or other carbapenem antibiotic Severe, life-threatening reaction to penicillin or cephalosporins Patients experiencing or with history of CNS disorders (eg: seizure, stroke) Patients experiencing CNS infection Inability to complete 24 hours of CVVHD Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis Inability to obtain informed consent Pregnant and/or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ertapenem<br>subjects will receive ertapenem while receiving CVVHD | Drug: ertapenem<br>* One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.<br>* Other names: Invanz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ertapenem Transmembrane Clearance by Continuous Hemodialysis. |  | 24 hours after receiving first 1 gram dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ertapenem, continuous hemodialysis, pharmacokinetics