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| Sponsor: | Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00596167 |
Purpose
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:
| Condition | Intervention |
|---|---|
|
End Stage Renal Disease Infection |
Drug: Intravenous levofloxacin, gentamicin, vancomycin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Intradialytic Drug Removal by Short-daily Hemodialysis |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Brian S Decker, MD, PharmD | Indiana University School of Medicine |
More Information
| Responsible Party: | Brian Scott Decker, Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00596167 History of Changes |
| Other Study ID Numbers: | 0609-18 |
| Study First Received: | January 7, 2008 |
| Last Updated: | October 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Short-daily hemodialysis pharmacokinetics levofloxacin gentamicin vancomycin |
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Gentamicins Ofloxacin Vancomycin Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Anti-Infective Agents, Urinary Renal Agents |
