Hub Cleansing to Prevent Hub Infection
HUC-PHIN
1 other identifier
interventional
149
1 country
1
Brief Summary
Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a superior disinfectant at the site of central venous catheter insertion. Scrub duration of central venous catheter hubs will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
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
First Submitted
Initial submission to the registry
February 15, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 18, 2016
CompletedApril 18, 2016
August 1, 2015
1.3 years
February 15, 2012
August 14, 2015
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Central Venous Catheter Hubs With Internal Contamination
This will be a qualitative outcome. It will be reported as "yes" or "no" for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms.
15 months
Secondary Outcomes (2)
Number of Contaminated Central Venous Catheter Tips
10 months
Median Number of Microbial Colony Forming Units Per Hub Interior
15 months
Study Arms (4)
Alcohol with 5 second scrub
EXPERIMENTAL70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Alcohol with 15 second scrub
EXPERIMENTAL70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Chlorhexidine with 5 second scrub
EXPERIMENTAL3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Chlorhexidine with 15 second scrub
EXPERIMENTAL3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Interventions
Scrub catheter hubs for 15 seconds before every access.
Scrub catheter hubs for 15 seconds before every access.
3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
Eligibility Criteria
You may qualify if:
- Medical intensive care unit patients with non-tunneled central venous catheters
You may not qualify if:
- Dialysis catheters
- Antibiotic-impregnated catheters
- Introducer sheaths
- Tunneled catheters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
* Single MICU * Large number of eligible hubs not evaluated * Unbalanced hub collection among study arms * Studied hub contamination only; unable to collect catheter tips * Did not study central-line associated bloodstream infection itself
Results Point of Contact
- Title
- Mary Hayden, MD
- Organization
- Rush University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mary K Hayden, MD
Rush University Medical Center
- PRINCIPAL INVESTIGATOR
Robert A Weinstein, MD
Cook County Health and Hospital Systems
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
March 27, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
April 18, 2016
Results First Posted
April 18, 2016
Record last verified: 2015-08
Data Sharing
- IPD Sharing
- Will share
Rush University Medical Center adheres to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts. Our response to requests for research resources from academic and other non-profit investigators will be timely and will be based on the Simple Letter Agreement for the Transfer of Materials as described in the Guidelines for Disseminating Research Resources Arising Out of NIH-Funded Research (Federal Register, Vol. 64, No 246, p.72094), and will not be more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). Any intellectual property resulting from this study that can be patented will remain easily and widely available to the researchers in accordance with the NIH Principles and Guidelines. Distribution of resources to for-profit entities may occur under material transfer agreements or non-exclusive license arrangements.