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Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848809
Recruitment Status : Withdrawn (PI had difficult enrollment.)
First Posted : February 20, 2009
Last Update Posted : April 22, 2015
Information provided by:
Avera McKennan Hospital & University Health Center

Brief Summary:
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 or disease Intervention/treatment
Acute Kidney Injury Procedure: Blood sample

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

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

Primary Outcome Measures :
  1. To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin. [ Time Frame: 4 months ]

Biospecimen Retention:   None Retained
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848809

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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
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Principal Investigator: Bradley Beck, Pharm.D. Avera McKennan Hospital and University Health Center

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Responsible Party: Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center Identifier: NCT00848809    
Other Study ID Numbers: 2008.073
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Avera McKennan Hospital & University Health Center:
Acute kidney injury
Vancomycin therapy
Slow-low efficiency daily dialysis
Intermittent Hemodialysis
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents