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Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

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ClinicalTrials.gov Identifier: NCT00877370
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 3, 2009
First Posted Date  ICMJE April 7, 2009
Results First Submitted Date  ICMJE August 29, 2012
Results First Posted Date  ICMJE September 28, 2012
Last Update Posted Date September 28, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
Ertapenem Transmembrane Clearance by Continuous Hemodialysis. [ Time Frame: 24 hours after receiving first 1 gram dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Amount of ertapenem removed by continuous dialysis [ Time Frame: 24 hours after receiving first 1 gram dose ]
Change History Complete list of historical versions of study NCT00877370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
Official Title  ICMJE Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Acute Kidney Failure
Intervention  ICMJE Drug: 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.
Other Name: Invanz
Study Arms  ICMJE Experimental: ertapenem
subjects will receive ertapenem while receiving CVVHD
Intervention: Drug: ertapenem
Publications * Eyler RF, Vilay AM, Nader AM, Heung M, Pleva M, Sowinski KM, DePestel DD, Sörgel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2009)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877370
Other Study ID Numbers  ICMJE HUM00022460
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruce A. Mueller, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce A Mueller, Pharm.D. University of Michigan
PRS Account University of Michigan
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP