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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
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Care Provider);   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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ( U.S. NIH Grant/Contract )
Study First Received: February 15, 2012
Results First Received: August 14, 2015
Last Updated: April 14, 2016