Hub Cleansing to Prevent Hub Infection

Not Applicable

Completed

Conditions: Bacteremia

Interventions: Other: 5 second scrub
Other: 15 second scrub
Drug: 70% isopropyl alcohol
Drug: 3.15% chlorhexidine/70% isopropyl alcohol

Registration Number: NCT01563406

Lead Sponsor: Rush University Medical Center

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 149

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

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Alcohol with 5 second scrub	70% isopropyl alcohol	70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Alcohol with 5 second scrub	5 second scrub	70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Chlorhexidine with 5 second scrub	5 second scrub	3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Alcohol with 15 second scrub	70% isopropyl alcohol	70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Chlorhexidine with 15 second scrub	15 second scrub	3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Alcohol with 15 second scrub	15 second scrub	70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Chlorhexidine with 5 second scrub	3.15% chlorhexidine/70% isopropyl alcohol	3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.
Chlorhexidine with 15 second scrub	3.15% chlorhexidine/70% isopropyl alcohol	3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.

Primary Outcome Measures

Name	Time	Method
Number of Central Venous Catheter Hubs With Internal Contamination	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.

Secondary Outcome Measures

Name	Time	Method
Number of Contaminated Central Venous Catheter Tips	10 months	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	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.