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Intradialytic Drug Removal by Short-daily Hemodialysis

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

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

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: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

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

Indiana University School of Medicine, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: September 2007
Last updated: October 12, 2011

Page last updated: August 23, 2015

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