Intradialytic Drug Removal by Short-daily Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Intradialytic Drug Removal by Short-daily Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596167
• Other study ID #: 0609-18
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: October 12, 2011
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Infection
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Decker BS, Kays MB, Chambers M, Kraus MA, Moe SM, Sowinski KM. Vancomycin pharmacokinetics and pharmacodynamics during short daily hemodialysis. Clin J Am Soc Nephrol. 2010 Nov;5(11):1981-7. doi: 10.2215/CJN.03450410. Epub 2010 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of levofloxacin, gentamicin and vancomycin in patients receiving short-daily hemodialysis		Serum levels of the three tested antibiotics will be measured before, during and at periodic intervals after a short-daily hemodialysis session	No