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NCT00780351 Clinical Trial

Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Acute Renal Failure Clinical Trial

Official title:
Pharmacokinetics and Dosing of Vancomycin in Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00780351
Other study ID # 200705036M
Secondary ID
Status Completed
Phase N/A
First received March 5, 2008
Last updated October 21, 2009
Start date October 2008
Est. completion date August 2009

Study information
Verified date October 2009
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

1. Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement therapy with high-flux dialyser membrane (helixone).

2. The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to be removed during dialysis.

3. Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find the most appropriate dose regimen for this kind of patients.

Description:

Vancomycin is the most important antibiotic in the treatment of resistant G(+) bacteria infections. Close monitor of serum level is important to ensure its safety and effectiveness. So far there is not enough data to support the optimal dose regimen of vancomycin in patients on SLEDD-f. In this study, we draw blood levels between 2 doses of vancomycin to determine the pharmacokinetic parameters of vancomycin and fraction removed by SLEDD-f so as to determine the most appropriate dose regimen.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date August 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute renal failure of any cause

- Use SLEDD-f as renal replacement therapy

- Priscribe vancomycin for a known or suspected infection

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• sustained low efficiency daily hemodiafiltration (SLEDD-f)
vancomycin 15mg/kg IV infusion on day 1 from 6PM to 8PM. Start SLEDD-f on day 2 from 9AM to 5PM.

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The amount of vancomycin removed during one course of SLEDD-f 8 hr (during one course of SLEDD-f) No
Primary The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f. 26 hr No
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