Study Stopped
PI had difficult enrollment.
Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedApril 22, 2015
April 1, 2015
4 months
February 19, 2009
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect of different types of renal replacement therapies on the elimination and volume of distribution of vancomycin.
4 months
Study Arms (2)
1
Slow-low efficiency daily dialysis group
2
Intermittent Hemodialysis group
Interventions
9 blood samples will be sent to the laboratory for the subjects in the SLED cohort
Eligibility Criteria
Patients must be admitted to the intensive care unit at Avera McKennan Hospital in Sioux Falls, SD.
You may qualify if:
- \> 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)
You may not qualify if:
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57117, United States
Related Publications (3)
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.
PMID: 16374156BACKGROUNDTrotman 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.
PMID: 16163635BACKGROUNDPai 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.
PMID: 15462252BACKGROUND
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Beck, Pharm.D.
Avera McKennan Hospital and University Health Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
December 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
April 22, 2015
Record last verified: 2015-04