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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Renal Failure
• Intervention / Treatment: Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in intensive care unit.

Description

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:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLEDD-f, vanco; Surgical ICU patients who is on slow low efficiency daily hemodiafiltration (SLEDD-f) and requires vancomycin therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Fe-Lin L Wu, MSCP, Ph.D., School of pharmacy, Graduate institute of clinical pharmacy, Department of Pharmacy of National Taiwan University Hospital, College of Medicine, National Taiwan University; Principal Investigator: Wen-Je Ko, MD, PhD, Department of Surgery, National Taiwan University Hospital, College of Medicine, National Taiwan University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: March 5, 2008
• First Submitted That Met QC Criteria: October 24, 2008
• First Posted (ESTIMATE): October 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 23, 2009
• Last Update Submitted That Met QC Criteria: October 21, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: vancomycin, SLEDD-f
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 200705036M