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Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

NCT ID: NCT00877370

Last Updated: 2012-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-03-31

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.

Conditions

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Acute Kidney Failure

Keywords

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ertapenem continuous hemodialysis pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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ertapenem

subjects will receive ertapenem while receiving CVVHD

Group Type EXPERIMENTAL

ertapenem

Intervention Type DRUG

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.

Interventions

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ertapenem

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.

Intervention Type DRUG

Other Intervention Names

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Invanz

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Bruce A. Mueller

Professor of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce A Mueller, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan University Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Eyler RF, Vilay AM, Nader AM, Heung M, Pleva M, Sowinski KM, DePestel DD, Sorgel F, Kinzig M, Mueller BA. Pharmacokinetics of ertapenem in critically ill patients receiving continuous venovenous hemodialysis or hemodiafiltration. Antimicrob Agents Chemother. 2014;58(3):1320-6. doi: 10.1128/AAC.02090-12. Epub 2013 Dec 9.

Reference Type DERIVED
PMID: 24323468 (View on PubMed)

Other Identifiers

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HUM00022460

Identifier Type: -

Identifier Source: org_study_id