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Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

This study has been terminated.
(PI had difficult enrollment.)
Sponsor:
Information provided by:
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT00848809
First received: February 19, 2009
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Kidney Injury
 Procedure: Blood sample

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Whole blood


Enrollment: 0
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Slow-low efficiency daily dialysis group
 Procedure: Blood sample
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
Other Name: Vancomycin level
2
Intermittent Hemodialysis group
 Procedure: Blood sample
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
Other Name: Vancomycin level

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.

  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 must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848809

Locations
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Bradley Beck, Pharm.D. Avera McKennan Hospital and University Health Center
  More Information

Publications:

Responsible Party: Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center
ClinicalTrials.gov Identifier: NCT00848809     History of Changes
Other Study ID Numbers: 2008.073
Study First Received: February 19, 2009
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
Acute kidney injury
Vancomycin therapy
Slow-low efficiency daily dialysis
Intermittent Hemodialysis
 Kidney
Vancomycin
Hemofiltration

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 June 18, 2013