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

October 21, 2009 updated by: National Taiwan University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 8 hr (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.
Time Frame: 26 hr
26 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200705036M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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