Intradialytic Drug Removal by Short-daily Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00596167
First received: January 7, 2008
Last updated: October 12, 2011
Last verified: October 2011
  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:

  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.

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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ]

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596167

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Brian S Decker, MD, PharmD Indiana University School of Medicine
  More Information

Publications:
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

Keywords provided by Indiana University:
Short-daily hemodialysis
pharmacokinetics
levofloxacin
gentamicin
vancomycin

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vancomycin
Gentamicins
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014