Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients

Corewell Health East7 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

ErtapenemDRUG

Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn

Eligibility

Sex: ALLMin age: 18 YearsMax age: 88 Years

Medical Language ↔ Plain English

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

Locations (1)

Oakwood Hospital - Dearborn

Dearborn, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to seven days after the administration of ertapenem