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OpenTrials
Completed

NCT Number: NCT00780351

Dosing Vancomycin in Patients on 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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sustained low efficiency daily hemodiafiltration (SLEDD-f)

Device

vancomycin 15mg/kg IV infusion on day 1 from 6PM to 8PM. Start SLEDD-f on day 2 from 9AM to 5PM.

Primary outcomes

  1. The amount of vancomycin removed during one course of SLEDD-f

    Time frame: 8 hr (during one course of SLEDD-f)

  2. The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f.

    Time frame: 26 hr

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2009
First posted
Oct 27, 2008
Registry last updated
Oct 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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