Intradialytic Drug Removal by Short-Daily Hemodialysis
Information source: Indiana University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Infection
Intervention: Intravenous levofloxacin, gentamicin, vancomycin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Brian S Decker, MD, PharmD, Principal Investigator, Affiliation: Indiana University School of Medicine
Overall contact:
Mary A Chambers, RN, Phone: (317) 274-7580, Email: marycham@iupui.edu
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:
1. Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and
levofloxacin by short-daily HD.
2. Determine the extent of vancomycin removal when administered during the last hour of
short-daily HD.
3. Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients
receiving short-daily HD.
Clinical Details
Official title: Intradialytic Drug Removal by Short-Daily Hemodialysis
Study design: Other, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Serum levels of levofloxacin, gentamicin and vancomycin in patients receiving short-daily hemodialysis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- > 18 years old
- currently receiving short-daily HD six times per week
- have no other acute intercurrent illness
Exclusion Criteria:
- history of a vancomycin, gentamicin or levofloxacin allergy
- weight within ± 30% of their ideal body weight
- Hgb < 10 mg/dl
Locations and Contacts
Mary A Chambers, RN, Phone: (317) 274-7580, Email: marycham@iupui.edu
Indiana University School of Medicine, Indianapolis, Indiana 46202, United States; Recruiting
Brian S Decker, MD, PharmD, Principal Investigator
Additional Information
Starting date: September 2007
Ending date: September 2009
Last updated: April 6, 2009
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