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
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Prevention
Condition: Bacteremia
Interventions: Other: 15 second scrub
Other: 5 second scrub
Drug: 3.15% chlorhexidine/70% isopropyl alcohol
Drug: 70% isopropyl alcohol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two separate wings of a 24-bed MICU were randomized to receive different intervention sequences. Wing A was assigned to a 15 sec scrub of 1) Alcohol; 2) chlorhexidine gluconate (CHG)+Alcohol; 3) Alcohol; and Wing B was assigned to a 5 sec scrub of 1) CHG+Alcohol; 2) Alcohol; 3) CHG+Alcohol.

Reporting Groups
  Description
Alcohol, 15 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
Chlorhexidine+Alcohol, 15 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
Alcohol, 5 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
Chlorhexidine+Alcohol, 5 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec

Participant Flow:   Overall Study
    Alcohol, 15 Second Scrub     Chlorhexidine+Alcohol, 15 Second Scrub     Alcohol, 5 Second Scrub     Chlorhexidine+Alcohol, 5 Second Scrub  
STARTED     60 [1]   30 [2]   30 [3]   29 [4]
COMPLETED     60 [1]   30 [2]   30 [3]   29 [4]
NOT COMPLETED     0     0     0     0  
[1] 194 hubs
[2] 102 hubs
[3] 101 hubs
[4] 112 hubs



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
140 participants, 149 separate MICU admissions, 509 hubs total. Each MICU admission is treated as a separate enrollment.

Reporting Groups
  Description
Alcohol, 15 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
Chlorhexidine+Alcohol, 15 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
Alcohol, 5 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
Chlorhexidine+Alcohol, 5 Second Scrub - Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
Total Total of all reporting groups

Baseline Measures
    Alcohol, 15 Second Scrub     Chlorhexidine+Alcohol, 15 Second Scrub     Alcohol, 5 Second Scrub     Chlorhexidine+Alcohol, 5 Second Scrub     Total  
Number of Participants  
[units: participants]
  60     30     30     29     149  
Age  
[units: years]
Mean (Standard Deviation)
  60  (17)     61  (12)     53  (17)     59  (17)     59  (16)  
Gender  
[units: participants]
         
Female     35     16     14     17     82  
Male     25     14     16     12     67  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  29  (9)     31  (11)     30  (14)     32  (13)     30  (11)  
Mechanical ventilation  
[units: participants]
         
Yes     37     20     24     19     100  
No     23     10     6     10     49  
Decubitus ulcer  
[units: participants]
         
Yes     24     11     8     9     52  
No     36     19     22     20     97  
Diarrhea  
[units: participants]
         
Yes     20     16     13     12     61  
No     40     14     17     17     88  
Diabetes  
[units: participants]
         
Yes     21     13     8     7     49  
No     39     17     22     22     100  
Heart disease  
[units: participants]
         
Yes     32     16     12     21     81  
No     28     14     18     8     68  
Pulmonary Disease  
[units: participants]
         
Yes     14     6     8     8     36  
No     46     24     22     21     113  
Liver disease  
[units: participants]
         
Yes     5     4     2     3     14  
No     55     26     28     26     135  
Central venous catheter (CVC) type  
[units: hubs]
         
Triple lumen     135     69     61     86     351  
PICC     59     33     40     26     158  
Anatomic location of CVC  
[units: hubs]
         
Internal/external jugular     102     70     65     58     295  
Basilic/cephalic/brachial     51     21     30     20     122  
Femoral     21     11     6     21     59  
Subclavian     18     0     0     13     31  
Unknown     2     0     0     0     2  
Time hub in place  
[units: hours]
Mean (Standard Deviation)
  95  (27)     101  (41)     100  (33)     94  (25)     97  (31)  
No. hubs per patient  
[units: hubs per patient]
Median (Inter-Quartile Range)
  3  
  (2 to 3)  
  3  
  (2 to 4)  
  3  
  (2 to 3)  
  3  
  (2 to 5)  
  3  
  (2 to 4)  



  Outcome Measures
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1.  Primary:   Number of Central Venous Catheter Hubs With Internal Contamination   [ Time Frame: 15 months ]

2.  Secondary:   Number of Contaminated Central Venous Catheter Tips   [ Time Frame: 10 months ]

3.  Secondary:   Median Number of Microbial Colony Forming Units Per Hub Interior   [ Time Frame: 15 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary Hayden, MD
Organization: Rush University Medical Center
phone: 3129428727
e-mail: mhayden@rush.edu



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
Results First Received: August 14, 2015
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government