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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00780351
First received: March 5, 2008
Last updated: October 21, 2009
Last verified: October 2009
History of Changes
  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)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics and Dosing of Vancomycin in Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Resource links provided by NLM:

U.S. FDA Resources

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

serum


Estimated Enrollment: 15
Study Start Date: October 2008
Study Completion Date: August 2009
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

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
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: Fe-Lin L Wu, Director, Department of Pharmacy, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00780351     History of Changes
Other Study ID Numbers: 200705036M
Study First Received: March 5, 2008
Last Updated: October 21, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013