Journal article
Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol
BMJ open, Vol.11(12), pp.e048830-e048830
12/03/2021
DOI: 10.1136/bmjopen-2021-048830
PMCID: PMC8647395
PMID: 34862278
Abstract
IntroductionApproximately 38% of haemodialysis patients carry Staphylococcus aureus in their noses, and carriers have a nearly four-fold increased risk of S. aureus access-related bloodstream infections (BSIs) compared with non-carriers. Our objective is to determine the clinical efficacy and effectiveness of a novel intervention using nasal povidone-iodine (PVI) to prevent BSIs among patients in haemodialysis units. We will survey patients and conduct qualitative interviews with healthcare workers to identify barriers and facilitators to implementing the intervention.Methods and analysisWe will perform an open-label, stepped-wedge cluster randomised trial to assess the effectiveness of nasal PVI compared with standard care. Sixteen outpatient haemodialysis units will participate in the study. The 3-year trial period will be divided into a 4-month baseline period and eight additional 4-month time blocks. The primary outcome of the study will be S. aureus BSI, defined as a S. aureus positive blood culture collected in the outpatient setting or within one calendar day after a hospital admission. The study team will evaluate characteristics of individual patients and the clusters by exposure status (control or intervention) to assess the balance between groups, and calculate descriptive statistics such as average responses separately for control and intervention survey questions.Ethics and disseminationThis study has received IRB approval from all study sites. A Data Safety and Monitoring Board will monitor this multicentre clinical trial. We will present our results at international meetings. The study team will publish findings in peer-reviewed journals and make each accepted peer-reviewed manuscript publicly available.Trial registration numberNCT04210505.
Details
- Title: Subtitle
- Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol
- Creators
- Ana-Monica Racila - Roy J. and Lucille A. Carver College of MedicineAmy M J O'Shea - University of IowaRajeshwari Nair - University of IowaKimberly Dukes - University of IowaLoreen A Herwaldt - University of IowaLinda Boyken - University of IowaDaniel Diekema - University of IowaMelissa A Ward - University of IowaJason Cobb - Emory UniversityJesse Jacob - Emory UniversityDavid Pegues - University of PennsylvaniaSusan Bleasdale - University of Illinois ChicagoAnitha Vijayan - Division of Nephrology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USAAnubha Mutneja - Washington University in St. LouisMony Fraer - University of IowaDebra O'Connell-Moore - University of Iowa Hospitals and ClinicsPam Tolomeo - University of PennsylvaniaMinerva Mendez - Emory UniversityErin Jaworski - University of Illinois ChicagoMarin L Schweizer - University of Iowa
- Resource Type
- Journal article
- Publication Details
- BMJ open, Vol.11(12), pp.e048830-e048830
- DOI
- 10.1136/bmjopen-2021-048830
- PMID
- 34862278
- PMCID
- PMC8647395
- NLM abbreviation
- BMJ Open
- ISSN
- 2044-6055
- eISSN
- 2044-6055
- Publisher
- British Medical Journal Publishing Group
- Grant note
- ISR74 / 3M (http://dx.doi.org/10.13039/100004343) UL1TR002537 / National Center For Advancing Translational Sciences of the National Institutes of Health 1R01HS026724-01 / Agency for Health Research and Quality (AHRQ)
- Language
- English
- Date published
- 12/03/2021
- Academic Unit
- Infectious Diseases; Epidemiology; Pathology; Nephrology; General Internal Medicine; Community and Behavioral Health; Internal Medicine
- Record Identifier
- 9984359854502771
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