Hub Cleansing to Prevent Hub Infection (HUC-PHIN)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01563406
First received: February 15, 2012
Last updated: April 2, 2014
Last verified: June 2013
  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:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Number of central venous catheter hubs with internal contamination [ Time Frame: 15 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 four study arms.


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".

  • Average number of microbial colony forming units per hub interior [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    This will be a quantitative outcome. It will be reported as the average number of microbial colony forming units isolated per hub interior. The average number of microbial colony forming units isolated per hub interior will be compared for the four study arms.


Enrollment: 509
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alcohol with 5 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
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: 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: Alcohol with 15 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
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: 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: Chlorhexidine with 5 second scrub
3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
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
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.
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

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 planned in an effort to balance the sizes of the study groups.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: April 2, 2014
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:
Infection
Communicable Diseases
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 September 16, 2014