Hub Cleansing to Prevent Hub Infection (HUC-PHIN)

April 14, 2016 updated by: Rush University Medical Center
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.

Study Overview

Detailed Description

A prospective randomized blinded crossover clinical trial will be performed in the medical intensive care unit at Rush University Medical Center. The intensive care unit will be divided into two regions (A&B). Hub disinfectants and duration of disinfection will be randomly assigned to these regions. After 1/2 of the study period, the agents will crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters.

In February 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. It was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible.

3/27/12-Internal hub contamination (yes/no)was clarified as the primary outcome.

On 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. The expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. This more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub.

The first crossover time selected was 6/11/12, prior to the midpoint of the study. This was done to try to improve a large imbalance in the group sizes.

On 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips.

On 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips.

On 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

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

    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical 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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical intensive care unit patients with non-tunneled central venous catheters

Exclusion Criteria:

  • Dialysis catheters
  • Antibiotic-impregnated catheters
  • Introducer sheaths
  • Tunneled catheters

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol with 5 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Scrub catheter hubs for 15 seconds before every access.
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.
Other Names:
  • Professional Disposable International Inc Alcohol Prep Pad
Experimental: Alcohol with 15 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
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.
Other Names:
  • Professional Disposable International Inc Alcohol Prep Pad
Scrub catheter hubs for 15 seconds before every access.
Experimental: Chlorhexidine with 5 second scrub
3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
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.
Other Names:
  • Professional Disposables International Inc. Chlorascrub Swab
Experimental: Chlorhexidine with 15 second scrub
3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
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.
Other Names:
  • Professional Disposables International Inc. Chlorascrub Swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Central Venous Catheter Hubs With Internal Contamination
Time Frame: 15 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Contaminated Central Venous Catheter Tips
Time Frame: 10 months
This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".
10 months
Median Number of Microbial Colony Forming Units Per Hub Interior
Time Frame: 15 months
This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mary K Hayden, MD, Rush University Medical Center
  • Principal Investigator: Robert A Weinstein, MD, Cook County Health and Hospital Systems

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

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

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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