Intradialytic Drug Removal by Short-daily Hemodialysis

NCT00596167 | Completed Results DMC

• 1 other identifier: 0609-18
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the interdialytic pharmacokinetics of vancomycin, gentamicin, and levofloxacin by short-daily HD.
2. 2.Determine the extent of vancomycin removal when administered during the last hour of short-daily HD.
3. 3.Develop drug-dosing guidelines for vancomycin, gentamicin and levofloxacin for patients receiving short-daily HD.

Conditions

End Stage Renal Disease; Infection

Keywords

Short-daily hemodialysis; pharmacokinetics; levofloxacin; gentamicin; vancomycin

Outcome Measures

Primary Outcomes (1)

• Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis

  The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis. (Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)

  Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).

Study Arms (1)

Intravenous antibiotics

EXPERIMENTAL

Intervention: administer intravenous vancomycin, gentamicin and levofloxacin. This study will determine the pharmacokinetics of intravenous vancomycin, gentamicin and levofloxacin in subjects receiving short-daily hemodialysis. There will not be a control arm for this study. The intervention for this arm will be to administer intravenous vancomycin, gentamicin and levofloxacin and draw blood samples at periodic intervals. The blood samples will be tested for these medications and pharmacokinetic analysis will be performed.

Drug: Intravenous antibiotics

Interventions

Intravenous antibiotics DRUG

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.

Also known as: Vancocin (vancomycin), Levaquin (levofloxacin), Gentamicin (gentamicin)

Intravenous antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• currently receiving short-daily HD six times per week
• have no other acute intercurrent illness

You may not qualify if:

• history of a vancomycin, gentamicin or levofloxacin allergy
• weight within ± 30% of their ideal body weight
• Hgb \< 10 mg/dl

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• 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.

  PMID: 20616157 RESULT

• Decker BS, Mohamed AN, Chambers M, Kraus MA, Moe SM, Sowinski KM. Gentamicin pharmacokinetics and pharmacodynamics during short-daily hemodialysis. Am J Nephrol. 2012;36(2):144-50. doi: 10.1159/000339937. Epub 2012 Jul 18.

  PMID: 22813936 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Infections

Interventions

Vancomycin; Levofloxacin; Gentamicins

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides

Limitations and Caveats

Overall limitation is the relatively small sample size.

Results Point of Contact

• Title: Brian Decker MD, PharmD
• Organization: Indiana University School of Medicine

bsdecker@iupui.edu

317-278-2868

Study Officials

• Brian S Decker, MD, PharmD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 25, 2016
• Results First Posted: March 25, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)