Hub Cleansing to Prevent Hub Infection (HUC-PHIN)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 15, 2012 | ||||||||
| Last Updated Date | March 26, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of central venous catheter hubs with internal contamination [ Time Frame: 10 months ] [ Designated as safety issue: No ] 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 two comparators (disinfecting agent and duration of cleansing). |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01563406 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Number of contaminated central venous catheter tips [ Time Frame: 10 months ] [ Designated as safety issue: No ] This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no". |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hub Cleansing to Prevent Hub Infection | ||||||||
| Official Title ICMJE | Hub Cleansing to Prevent Hub Infection | ||||||||
| 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 2X2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
||||||||
| Condition ICMJE | Catheter-related Bloodstream Infection | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01563406 | ||||||||
| Other Study ID Numbers ICMJE | U54CK000161-01W1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Rush University Medical Center | ||||||||
| Study Sponsor ICMJE | Rush University Medical Center | ||||||||
| Collaborators ICMJE | Centers for Disease Control and Prevention | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Rush University Medical Center | ||||||||
| Verification Date | March 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||