Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00848809
Recruitment Status : Withdrawn (PI had difficult enrollment.)
First Posted : February 20, 2009
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Avera McKennan Hospital & University Health Center

Tracking Information
First Submitted Date February 19, 2009
First Posted Date February 20, 2009
Last Update Posted Date April 22, 2015
Study Start Date December 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2009)
To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin. [ Time Frame: 4 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00848809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy
Official Title Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Patients must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.
Condition Acute Kidney Injury
Intervention
  • Procedure: Blood sample
    9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
    Other Name: Vancomycin level
  • 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
Study Groups/Cohorts
  • 1
    Slow-low efficiency daily dialysis group
    Intervention: Procedure: Blood sample
  • 2
    Intermittent Hemodialysis group
    Intervention: Procedure: Blood sample
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 10, 2011)
0
Original Estimated Enrollment
 (submitted: February 19, 2009)
20
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00848809
Other Study ID Numbers 2008.073
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center
Study Sponsor Avera McKennan Hospital & University Health Center
Collaborators Not Provided
Investigators
Principal Investigator: Bradley Beck, Pharm.D. Avera McKennan Hospital and University Health Center
PRS Account Avera McKennan Hospital & University Health Center
Verification Date April 2015