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Trial record 22 of 10491 for:    Anti-Infective Agents AND Bacterial

Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit

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: NCT03172039
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Marisa Battistella, University Health Network, Toronto

Brief Summary:
This quality improvement study will assess the antimicrobial use and prescribing practices of hospital and community prescribers for the ambulatory hemodialysis (HD) population in an urban academic outpatient HD unit in Ontario. Currently, in the outpatient HD unit at Toronto General Hospital (TGH), it is the standard of care for the patients to be screened on a weekly basis by the nephrology care team for the use of any oral or intravenous antimicrobials. Patient charts, pharmacy patient profiles and electronic medical records for these patients from September 1 2016 - April 30 2017 will be retrospectively reviewed in order to characterize antimicrobial use and its concordance with available clinical guidelines and antimicrobial stewardship principles described by the Centers for Disease Control and Prevention (CDC). The primary objective of the study is to determine the prevalence of antimicrobial use in an ambulatory HD population. The secondary objective of the study is to determine the congruence of prescribed antimicrobial regimens with available clinical guidelines and antimicrobial stewardship principles described by the CDC. It is hypothesized that antimicrobial use among HD patients will be common and that antimicrobial prescribing practices are not congruent with recommendations from published clinical guidelines and antimicrobial stewardship principles for a significant proportion of patients included in the retrospective review. Descriptive analysis of the data will summarize the findings. Future research will build upon the results of this project, and may include the development of interventions that target gaps in knowledge and prescribing behaviours of prescribers who provide care to the ambulatory HD population.

Condition or disease
End Stage Renal Failure on Dialysis Infection, Bacterial

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Dialysis




Primary Outcome Measures :
  1. Prevalence of antimicrobial prescriptions in an ambulatory hemodialysis population [ Time Frame: September 1 2016 - April 30 2017 ]
    Prevalence will be determined by the total number of antimicrobial prescriptions in the study population over the period of study. An antimicrobial prescription will be defined as any oral or intravenous antibacterial or antifungal or antiviral agent prescribed by a community or hospital prescriber to a patient receiving hemodialysis (HD) from Toronto General Hospital's outpatient HD unit. An antimicrobial prescription will follow the 21-day rule.The 21-day rule is that there must be 21 or more days from the end of one antimicrobial course to the beginning of a second antimicrobial course for two courses to be reported as separate prescriptions. If antimicrobials are stopped for fewer than 21 days and then restarted, the second start is not considered a new prescription, and therefore will not be reported.


Secondary Outcome Measures :
  1. Congruence of prescribed antimicrobial regimens [ Time Frame: September 1 2016 - April 30 2017 ]

    Proportion of antimicrobial prescriptions congruent with available clinical guidelines and antimicrobial stewardship principles based on:

    i) indication ii) antimicrobial agent iii) spectrum of activity against most likely causative pathogen iv) dose v) route of administration vi) dosing frequency vii) length of treatment




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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
The population to be studied in this retrospective chart review includes patients with end-stage renal disease receiving outpatient hemodialysis (HD) treatment at Toronto General Hospital (TGH) who were prescribed at least one antimicrobial during the study period.
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • Receiving outpatient hemodialysis (HD) for at least 3 months
  • Prescribed at least one oral or intravenous antimicrobial (antibacterial or antifungal or antiviral) by a hospital or community prescriber between September 2016 to April 30 2017 inclusive

Exclusion Criteria:

  • In-patients admitted to hospital

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 ClinicalTrials.gov identifier (NCT number): NCT03172039


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: Marisa Battistella, Clinician Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03172039     History of Changes
Other Study ID Numbers: 16-6388
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marisa Battistella, University Health Network, Toronto:
hemodialysis
antimicrobial stewardship
antimicrobial agents
bacterial infections
ambulatory care

Additional relevant MeSH terms:
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Bacterial Infections
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Anti-Bacterial Agents
Anti-Infective Agents