- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848809
Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy
April 21, 2015 updated by: Avera McKennan Hospital & University Health Center
Pharmacokinetics of Vancomycin in Various Modalities of Renal Replacement Therapy in the Intensive Care Unit
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117
- Avera McKennan Hospital and University Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Slow-low efficiency daily dialysis group
|
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
Other Names:
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
Other Names:
|
2
Intermittent Hemodialysis group
|
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
Other Names:
10 blood samples will be collected and sent to the laboratory for the subjects in the intermittent hemodialysis cohort.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin.
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bradley Beck, Pharm.D., Avera McKennan Hospital and University Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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