Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

Overview

This study is an observational analysis that monitors the effect of different dialysis methods on vancomycin levels when patients are critically ill. No changes are made to therapy based on levels, but levels are checked more frequently than normal. The primary dialysis methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent hemodialysis. Vancomycin is the only medication being evaluated in this study. This study will provide detailed information on how to dose vancomycin in patients that are on dialysis in the intensive care unit.

Full Title of Study: “Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2009

Detailed Description

The proposed study will evaluate the pharmacokinetics of vancomycin in patients that are on being treated with various types of renal replacement therapy. The renal replacement therapies studied in this trial will be slow-low efficiency daily (SLED) dialysis and intermittent hemodialysis. This data will be collected and plotted for vancomycin for each dialysis mechanism utilized and plotted on drug concentration versus time graphs to determine drug clearance in each type of renal replacement therapy. Subjects will have blood samples drawn and sent to the laboratory according to the dialysis method studied (9 for SLED dialysis and 10 samples for intermittent hemodialysis). Serial levels will be drawn prior to the drug being administered and after the drug is infused to assess the clearance and distribution of vancomycin. Study drug levels will be drawn from blood that is already available in the laboratory when timing of such samples is appropriate, in order to limit the amount of blood that is drawn from each study subject. A total of 30 milliliters of blood will be collected from each subject for any one study arm they fit into. Blood will be collected no more than two times per week and only more than once in a particular patient if their dialysis regimen changes. A single particular subject will only be able to supply blood samples once for each dialysis regimen being studied. This study would allow for the data collection of vancomycin levels at several time points during renal replacement therapy to assess the pharmacokinetic parameters associated with vancomycin dosing in each specialized patient-dialysis combination.

Interventions

  • Procedure: Blood sample
    • 9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
  • Procedure: Blood sample
    • 10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.

Arms, Groups and Cohorts

  • 1
    • Slow-low efficiency daily dialysis group
  • 2
    • Intermittent Hemodialysis group

Clinical Trial Outcome Measures

Primary Measures

  • To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin.
    • Time Frame: 4 months

Participating in This Clinical Trial

Inclusion Criteria

  • > 18 years of age – One of the following types of dialysis modalities implemented: Slow-low efficiency daily dialysis Intermittent hemodialysis – Use of study medication (vancomycin) Exclusion Criteria:

  • Inability to give informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Avera McKennan Hospital & University Health Center
  • Provider of Information About this Clinical Study
    • Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center
  • Overall Official(s)
    • Bradley Beck, Pharm.D., Principal Investigator, Avera McKennan Hospital and University Health Center

References

Kielstein JT, Czock D, Schopke T, Hafer C, Bode-Boger SM, Kuse E, Keller F, Fliser D. Pharmacokinetics and total elimination of meropenem and vancomycin in intensive care unit patients undergoing extended daily dialysis. Crit Care Med. 2006 Jan;34(1):51-6. doi: 10.1097/01.ccm.0000190243.88133.3f.

Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. doi: 10.1086/444500. Epub 2005 Sep 12.

Pai AB, Pai MP. Vancomycin dosing in high flux hemodialysis: a limited-sampling algorithm. Am J Health Syst Pharm. 2004 Sep 1;61(17):1812-6. doi: 10.1093/ajhp/61.17.1812.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.