- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563406
Hub Cleansing to Prevent Hub Infection (HUC-PHIN)
Study Overview
Status
Conditions
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 implemented in an effort to balance the sizes of the study groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical intensive care unit patients with non-tunneled central venous catheters
Exclusion Criteria:
- Dialysis catheters
- Antibiotic-impregnated catheters
- Introducer sheaths
- Tunneled catheters
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol with 5 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
|
Scrub catheter hubs for 15 seconds before every access.
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 Names:
|
Experimental: Alcohol with 15 second scrub
70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
|
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 Names:
Scrub catheter hubs for 15 seconds before every access.
|
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.
|
Scrub catheter hubs for 15 seconds before every access.
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 Names:
|
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.
|
Scrub catheter hubs for 15 seconds before every access.
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Central Venous Catheter Hubs With Internal Contamination
Time Frame: 15 months
|
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.
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15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Contaminated Central Venous Catheter Tips
Time Frame: 10 months
|
This will be a qualitative measure for central venous catheter tip contamination.
The results will be reported as "yes" or "no".
|
10 months
|
Median Number of Microbial Colony Forming Units Per Hub Interior
Time Frame: 15 months
|
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.
|
15 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary K Hayden, MD, Rush University Medical Center
- Principal Investigator: Robert A Weinstein, MD, Cook County Health and Hospital Systems
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sepsis
- Bacteremia
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Disinfectants
- Ethanol
- Chlorhexidine
Other Study ID Numbers
- U54CK000161-01W1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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