Intradialytic Drug Removal by Short-daily Hemodialysis
| Tracking Information | |||||
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| First Received Date ICMJE | January 7, 2008 | ||||
| Last Updated Date | October 12, 2011 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Serum levels of levofloxacin, gentamicin and vancomycin in patients receiving short-daily hemodialysis [ Time Frame: Serum levels of the three tested antibiotics will be measured before, during and at periodic intervals after a short-daily hemodialysis session ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00596167 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intradialytic Drug Removal by Short-daily Hemodialysis | ||||
| Official Title ICMJE | Intradialytic Drug Removal by Short-daily Hemodialysis | ||||
| Brief Summary | Short-daily hemodialysis is increasingly becoming a preferred alternative to the conventional intermittent (three times per week) hemodialysis schedule. Studies have shown that short-daily dialysis improves a patient's quality of life, high blood pressure, anemia and calcium-phosphorus balance. Infection, however, will likely remain a persistent problem for dialysis patients regardless of the frequency of treatments. There is currently a wealth of information to guide doctors on how much and how frequently to give an antibiotic for patients who receive intermittent (thrice weekly) hemodialysis. However, there is very little information on how to prescribe antibiotics for patient's receiving short-daily hemodialysis. This study will develop drug dose guidelines for patients receiving short-daily hemodialysis for three frequently used antibiotics, vancomycin, levofloxacin and gentamicin. These guidelines will assist doctors so that patients receive the most effective dose and frequency of an antibiotic to treat their infection. The following is the study hypothesis which will be tested with two-sided, one sample t-tests comparing the AUC observed to historical measures8. 1) Vancomycin, levofloxacin and gentamicin are removed to a greater extent by short-daily hemodialysis than intermittent hemodialysis. The following are the specific aims:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Intravenous levofloxacin, gentamicin, vancomycin
Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through the venous limb of their HD access (or tunneled catheter) via an IV pump. |
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| Study Arm (s) | Experimental: I
This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
Intervention: Drug: Intravenous levofloxacin, gentamicin, vancomycin |
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| Publications * | Decker BS, Kays MB, Chambers M, Kraus MA, Moe SM, Sowinski KM. Vancomycin pharmacokinetics and pharmacodynamics during short daily hemodialysis. Clin J Am Soc Nephrol. 2010 Nov;5(11):1981-7. Epub 2010 Jul 8. | ||||
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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 | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | April 2009 (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 | NCT00596167 | ||||
| Other Study ID Numbers ICMJE | 0609-18 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Brian Scott Decker, Indiana University School of Medicine | ||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||
| Verification Date | October 2011 | ||||
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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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