CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Intravenous antibioticsdrug
Likely dose
Intravenous antibiotics 15 mg/kgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00596167
NCT00596167N/ACompleted

Intradialytic Drug Removal by Short-daily Hemodialysis

Indiana University·interventional·Posted Jan 16, 2008·Updated Mar 25, 2016

In Brief

A clinical study evaluating Intravenous antibiotics for End Stage Renal Disease and Infection. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.5 years ago

Interventions

Intravenous antibioticsdrug

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.