Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

Detailed Description
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After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

Official Title
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Pharmacokinetics and Investigation of Optimal Dose of Invanz (Ertapenem) in Hemodialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Ertapenem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and Medical Center during January 1, 2014 or date of Institutional Review Board (IRB) approval to December 1, 2015 Diagnosed with end stage renal disease and requires hemodialysis three times a week No allergy to β lactam medications Existing IV access for parenteral ertapenem infusion Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and pre-hemodialysis for the following hemodialysis and immediately post hemodialysis session and 1 hour post. No evidence of hepatic disease No history of alcoholism or drug abuse within pervious 2 years Not pregnant Exclusion Criteria: History of any form of epilepsy, seizure or convulsion Currently taking any forms of valproic acid or divalproex sodium for treatment of any disease states Currently taking probenecid Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1 of receiving ertapenem for this study Currently receiving any antimicrobial agents for prophylaxis or treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem<br>Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session | Drug: Ertapenem<br>* Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn<br>* Other names: Invanz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients | Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | 
| Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients | Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | 
| Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients | Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | 
| Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients | Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | 
| Mean Time to Cmax of Ertapenem in Hemodialysis Patients | Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Diarrhea | Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital | Up to seven days after the administration of ertapenem | 
| Number of Participants With Nausea and Vomiting | Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital | Up to seven days after the administration of ertapenem | 
| Number of Participants With Headache | Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital | Up to seven days after the administration of ertapenem | 
| Number of Participants With Injection Site Reaction | Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital | Up to seven days after the administration of ertapenem | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ertapenem, pharmacokinetic, pharmacodynamics, hemodialysis, requires hemodialysis three times a week