Hub Cleansing to Prevent Hub Infection (HUC-PHIN)

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by (Responsible Party):

Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT01563406

First received: February 15, 2012

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention
Catheter-related Bloodstream Infection	Other: 15 second scrub Other: 5 second scrub Drug: 3.15% chlorhexidine/70% isopropyl alcohol Drug: 70% isopropyl alcohol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Hub Cleansing to Prevent Hub Infection

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Isopropyl alcohol Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

Number of central venous catheter hubs with internal contamination [ Time Frame: 10 months ] [ Designated as safety issue: No ]
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 two comparators (disinfecting agent and duration of cleansing).

Secondary Outcome Measures:

Number of contaminated central venous catheter tips [ Time Frame: 10 months ] [ Designated as safety issue: No ]
This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".

Estimated Enrollment:	800
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Region A One region of the MICU at Rush University Medical Center will be designated region A.	Other: 15 second scrub Catheter hubs are normally cleansed prior to accessing the central venous line. All catheter hubs in this arm will be scrubbed for 15 seconds. Drug: 3.15% chlorhexidine/70% isopropyl alcohol 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 Name: Professional Disposables International, Inc. (PDI) Chlorascrub Swab Drug: 70% isopropyl alcohol 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 Name: Professional Disposable International, Inc. (PDI) Alcohol Prep Pad
Experimental: Region B One region of the MICU at Rush University Medical Center will be designated region B.	Other: 5 second scrub Catheter hubs are normally cleansed prior to accessing the central venous line. All catheter hubs in this arm will be scrubbed for 5 seconds. Drug: 3.15% chlorhexidine/70% isopropyl alcohol 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 Name: Professional Disposables International, Inc. (PDI) Chlorascrub Swab Drug: 70% isopropyl alcohol 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 Name: Professional Disposable International, Inc. (PDI) Alcohol Prep Pad

Arms

Assigned Interventions

Experimental: Region A

One region of the MICU at Rush University Medical Center will be designated region A.

Other: 15 second scrub

Catheter hubs are normally cleansed prior to accessing the central venous line. All catheter hubs in this arm will be scrubbed for 15 seconds.

Drug: 3.15% chlorhexidine/70% isopropyl alcohol

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 Name: Professional Disposables International, Inc. (PDI) Chlorascrub Swab

Drug: 70% isopropyl alcohol

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 Name: Professional Disposable International, Inc. (PDI) Alcohol Prep Pad

Experimental: Region B

One region of the MICU at Rush University Medical Center will be designated region B.

Other: 5 second scrub

Catheter hubs are normally cleansed prior to accessing the central venous line. All catheter hubs in this arm will be scrubbed for 5 seconds.

Drug: 3.15% chlorhexidine/70% isopropyl alcohol

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 Name: Professional Disposables International, Inc. (PDI) Chlorascrub Swab

Drug: 70% isopropyl alcohol

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 Name: Professional Disposable International, Inc. (PDI) Alcohol Prep Pad

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 2X2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Dialysis catheters
Antibiotic-impregnated catheters
Introducer sheaths
Tunneled catheters

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563406

Locations

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

Sponsors and Collaborators

Rush University Medical Center

Centers for Disease Control and Prevention

Investigators

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

More Information

No publications provided

Responsible Party:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT01563406 History of Changes
Other Study ID Numbers:	U54CK000161-01W1
Study First Received:	February 15, 2012
Last Updated:	March 26, 2012
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Rush University Medical Center:

Needleless connectors
catheter hubs

Additional relevant MeSH terms:

Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013

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