Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
This study has been completed.
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan
ClinicalTrials.gov Identifier:
NCT00877370
First received: April 3, 2009
Last updated: August 29, 2012
Last verified: August 2012
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 3, 2009 | ||||
| Last Updated Date | August 29, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ertapenem Transmembrane Clearance by Continuous Hemodialysis. [ Time Frame: 24 hours after receiving first 1 gram dose ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Amount of ertapenem removed by continuous dialysis [ Time Frame: 24 hours after receiving first 1 gram dose ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00877370 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
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| 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 |
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| Study Arm (s) | Experimental: ertapenem
subjects will receive ertapenem while receiving CVVHD
Intervention: Drug: ertapenem |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00877370 | ||||
| Other Study ID Numbers ICMJE | HUM00022460 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bruce A. Mueller, University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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