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Hub Cleansing to Prevent Hub Infection (HUC-PHIN)

This study has been completed.
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: April 14, 2016
Last verified: August 2015

February 15, 2012
April 14, 2016
March 2012
June 2013   (final data collection date for primary outcome measure)
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.
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).
Complete list of historical versions of study NCT01563406 on ClinicalTrials.gov Archive Site
  • 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".
  • Median 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 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.
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".
Not Provided
Not Provided
 
Hub Cleansing to Prevent Hub Infection
Hub Cleansing to Prevent Hub Infection
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Bacteremia
  • Other: 15 second scrub
    Scrub catheter hubs for 15 seconds before every access.
  • Other: 5 second scrub
    Scrub catheter hubs for 15 seconds before every access.
  • 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. 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 Alcohol Prep Pad
  • Experimental: Alcohol with 5 second scrub
    70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
    Interventions:
    • Other: 5 second scrub
    • Drug: 70% isopropyl alcohol
  • Experimental: Alcohol with 15 second scrub
    70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
    Interventions:
    • Other: 15 second scrub
    • Drug: 70% isopropyl alcohol
  • 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.
    Interventions:
    • Other: 5 second scrub
    • Drug: 3.15% chlorhexidine/70% isopropyl alcohol
  • 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.
    Interventions:
    • Other: 15 second scrub
    • Drug: 3.15% chlorhexidine/70% isopropyl alcohol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Dialysis catheters
  • Antibiotic-impregnated catheters
  • Introducer sheaths
  • Tunneled catheters
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01563406
U54CK000161-01W1
No
Yes
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.
Rush University Medical Center
Rush University Medical Center
Centers for Disease Control and Prevention
Principal Investigator: Mary K Hayden, MD Rush University Medical Center
Principal Investigator: Robert A Weinstein, MD Cook County Health and Hospital Systems
Rush University Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP