Clinical trial NCT01563406
Conditions: Bacteremia
Keywords: Needleless connectors catheter hubs
Sponsor: Rush University Medical Center
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

Arms: arm 1: 70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. arm 2: 70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. arm 3: 3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. arm 4: 3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.
Interventions: intervention 1: 15 second scrub intervention 2: 5 second scrub intervention 3: 3.15% chlorhexidine/70% isopropyl alcohol intervention 4: 70% isopropyl alcohol
Intervention descriptions: intervention 1: Scrub catheter hubs for 15 seconds before every access. intervention 2: Scrub catheter hubs for 15 seconds before every access. intervention 3: 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. intervention 4: 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.

Protocol documents: