Hub Cleansing to Prevent Hub Infection

Catheter-related Bloodstream Infection Clinical Trial

— HUC-PHIN  

Official title:

Hub Cleansing to Prevent Hub Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563406
• Other study ID #: U54CK000161-01W1
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: April 2, 2014
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-related Bloodstream Infection
• Infection

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of central venous catheter hubs with internal contamination	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.	15 months	No
Secondary	Number of contaminated central venous catheter tips	This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".	10 months	No
Secondary	Average number of microbial colony forming units per hub interior	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.	15 months	No