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Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, October 2008
First Received: March 5, 2008   Last Updated: October 24, 2008   History of Changes
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00780351
  Purpose
  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.

Condition Intervention
Acute Renal Failure
 Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)

MedlinePlus related topics: Kidney Failure
Drug Information available for: Vancomycin Vancomycin hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Pharmacokinetics and Dosing of Vancomycin in Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The amount of vancomycin removed during one course of SLEDD-f [ Time Frame: 8 hr (during one course of SLEDD-f) ] [ Designated as safety issue: No ]
  • The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f. [ Time Frame: 26 hr ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

serum


Estimated Enrollment: 15
Study Start Date: October 2008
Estimated Study Completion Date: December 2008
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in intensive care unit.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780351

Contacts
Contact: Fe-Lin L Wu, Ph.D. +886-2-23123456 ext 8389 flwu@ntu.edu.tw
Contact: Wen-Je Ko, MD, Ph.D. +886-2-23123456 ext 3098 wenje@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Fe-Lin L Wu, Ph.D.     +886-2-23123456 ext 8389     flwu@ntu.edu.tw    
Contact: Wen-Je Ko, MD,Ph.D.     +886-2-23123456 ext 3098     kowj@ntu.edu.tw    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Department of Pharmacy, National Taiwan University Hospital ( Fe-Lin L Wu, Director )
Study ID Numbers: 200705036M
Study First Received: March 5, 2008
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00780351     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
vancomycin, SLEDD-f

Study placed in the following topic categories:
Anti-Bacterial Agents
Renal Insufficiency
Urologic Diseases
Vancomycin
 Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Renal Insufficiency
Urologic Diseases
Therapeutic Uses
Vancomycin
 Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009



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