Catheter-related Bloodstream Infection Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05729321 -
Lock sOlutiOnS for Epicutaneo-caval Catheters in Neonates: a "LOOSEN" Pilot Study
|
||
| Not yet recruiting |
NCT06019897 -
Impact of Tubing Colonization on the Incidence of Central Venous Catheter Infection
|
||
| Recruiting |
NCT05264402 -
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
|
||
| Recruiting |
NCT01603914 -
Central Venous Catheter Replacement Strategies in Adult Patients With Major Burn Injury
|
N/A | |
| Not yet recruiting |
NCT04856878 -
Effect of Vancomycin After Catheter Replacement
|
Phase 4 | |
| Completed |
NCT01249976 -
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children
|
N/A | |
| Completed |
NCT00548132 -
Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)
|
Phase 4 | |
| Not yet recruiting |
NCT02990923 -
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
|
Phase 4 | |
| Completed |
NCT04822467 -
SQ53 Disinfectant Wipes for Prevention of CRBSI
|
N/A | |
| Completed |
NCT06216184 -
Adding Vortexing to the Maki Technique Provides no Benefit for the Diagnosis of Catheter-related Bacteremia
|