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Completed

NCT Number: NCT01563406

Hub Cleansing to Prevent Hub Infection

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical intensive care unit patients with non-tunneled central venous catheters

Exclusion criteria

  • Dialysis catheters
  • Antibiotic-impregnated catheters
  • Introducer sheaths
  • Tunneled catheters

Treatment and study plan

15 second scrub

Other

Scrub catheter hubs for 15 seconds before every access.

5 second scrub

Other

Scrub catheter hubs for 15 seconds before every access.

3.15% chlorhexidine/70% isopropyl alcohol

Drug

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: Professional Disposables International Inc. Chlorascrub Swab

70% isopropyl alcohol

Drug

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: Professional Disposable International Inc Alcohol Prep Pad

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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".

  2. 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Acronym: HUC-PHIN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2012
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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