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

Completed

• Conditions: Acute Renal Failure
• Interventions: Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)

• Registration Number: NCT00780351
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-03-05
• Study Start: 2008-10
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Study Completion: 2009-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-21
• Last Update Posted: 2009-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Acute renal failure of any cause
• Use SLEDD-f as renal replacement therapy
• Priscribe vancomycin for a known or suspected infection

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLEDD-f, vanco	sustained low efficiency daily hemodiafiltration (SLEDD-f)	Surgical ICU patients who is on slow low efficiency daily hemodiafiltration (SLEDD-f) and requires vancomycin therapy

Primary Outcome Measures

Name	Time	Method
The amount of vancomycin removed during one course of SLEDD-f	8 hr (during one course of SLEDD-f)
The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f.	26 hr

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan