BacteremiaHUC-PHINNCT01563406
Hub Cleansing to Prevent Hub Infection
A study testing 15 second scrub, 5 second scrub and 3.15% chlorhexidine/70% isopropyl alcohol in people with Bacteremia, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- 15 second scrub, 5 second scrub and 3.15% chlorhexidine/70% isopropyl alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical intensive care unit patients with non-tunneled central venous catheters
Who cannot join
- Dialysis catheters
- Antibiotic-impregnated catheters
- Introducer sheaths
- Tunneled catheters
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Bacteremia
- Being tested
- 15 second scrub, 5 second scrub, 3.15% chlorhexidine/70% isopropyl alcohol, 70% isopropyl alcohol
- Keywords
- Needleless connectors, catheter hubs
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 second scrubOther
Scrub catheter hubs for 15 seconds before every access.
5 second scrubOther
Scrub catheter hubs for 15 seconds before every access.
3.15% chlorhexidine/70% isopropyl alcoholDrug
Also called Professional Disposables International Inc. Chlorascrub Swab
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.
70% isopropyl alcoholDrug
Also called Professional Disposable International Inc Alcohol Prep Pad
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.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol with 5 second scrub | Experimental | 70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. Receives: Other: 5 second scrub; Drug: 70% isopropyl alcohol |
| Alcohol with 15 second scrub | Experimental | 70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. Receives: Other: 15 second scrub; Drug: 70% isopropyl alcohol |
| Chlorhexidine with 5 second scrub | Experimental | 3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. Receives: Other: 5 second scrub; Drug: 3.15% chlorhexidine/70% isopropyl alcohol |
| Chlorhexidine with 15 second scrub | Experimental | 3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. Receives: Other: 15 second scrub; Drug: 3.15% chlorhexidine/70% isopropyl alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Central Venous Catheter Hubs With Internal Contamination
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.
Measured: 15 months
Secondary outcomes (2)
Number of Contaminated Central Venous Catheter Tips
This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".
Measured: 10 months
Median Number of Microbial Colony Forming Units Per Hub Interior
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Mary K Hayden, MD, Principal investigator, Rush University Medical CenterRobert A Weinstein, MD, Principal investigator, Cook County Health and Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563406
- Sponsor's protocol ID
- U54CK000161-01W1
- Acronym
- HUC-PHIN
- Status last verified
- Aug 2015
- First submitted
- 15 Feb 2012
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Rush University Medical Center adheres to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts. Our response to requests for research resources from academic and other non-profit investigators will be timely and will be based on the Simple Letter Agreement for the Transfer of Materials as described in the Guidelines for Disseminating Research Resources Arising Out of NIH-Funded Research (Federal Register, Vol. 64, No 246, p.72094), and will not be more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). Any intellectual property resulting from this study that can be patented will remain easily and widely available to the researchers in accordance with the NIH Principles and Guidelines. Distribution of resources to for-profit entities may occur under material transfer agreements or non-exclusive license arrangements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hub Cleansing to Prevent Hub Infection
- ClinicalTrials.gov ID
- NCT01563406
- Acronym / sponsor ID
- HUC-PHIN / U54CK000161-01W1
- Conditions
- Bacteremia
- Keywords
- Needleless connectors, catheter hubs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol with 5 second scrub | Experimental | Other: 5 second scrub, Drug: 70% isopropyl alcohol70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. |
| Alcohol with 15 second scrub | Experimental | Other: 15 second scrub, Drug: 70% isopropyl alcohol70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. |
| Chlorhexidine with 5 second scrub | Experimental | Other: 5 second scrub, Drug: 3.15% chlorhexidine/70% isopropyl alcohol3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds. |
| Chlorhexidine with 15 second scrub | Experimental | Other: 15 second scrub, Drug: 3.15% chlorhexidine/70% isopropyl alcohol3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical intensive care unit patients with non-tunneled central venous catheters
Key exclusion criteria (4 listed)
- Dialysis catheters
- Antibiotic-impregnated catheters
- Introducer sheaths
- Tunneled catheters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 second scrubScrub catheter hubs for 15 seconds before every access. | Other | Alcohol with 15 second scrub, Chlorhexidine with 15 second scrub |
| 5 second scrubScrub catheter hubs for 15 seconds before every access. | Other | Alcohol with 5 second scrub, Chlorhexidine with 5 second scrub |
| 3.15% chlorhexidine/70% isopropyl alcoholAlso: Professional Disposables International Inc. Chlorascrub Swab3.15% 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. | Drug | Chlorhexidine with 15 second scrub, Chlorhexidine with 5 second scrub |
| 70% isopropyl alcoholAlso: Professional Disposable International Inc Alcohol Prep Pad70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period. | Drug | Alcohol with 15 second scrub, Alcohol with 5 second scrub |
Primary outcome
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.
2 secondary outcomes
Number of Contaminated Central Venous Catheter Tips
Time frame: 10 months
Median Number of Microbial Colony Forming Units Per Hub Interior
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Rush University Medical Center adheres to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts. Our response to requests for research resources from academic and other non-profit investigators will be timely and will be based on the Simple Letter Agreement for the Transfer of Materials as described in the Guidelines for Disseminating Research Resources Arising Out of NIH-Funded Research (Federal Register, Vol. 64, No 246, p.72094), and will not be more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). Any intellectual property resulting from this study that can be patented will remain easily and widely available to the researchers in accordance with the NIH Principles and Guidelines. Distribution of resources to for-profit entities may occur under material transfer agreements or non-exclusive license arrangements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary K Hayden, MD principal investigator
Rush University Medical Center
Robert A Weinstein, MD principal investigator
Cook County Health and Hospital Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 second scrub, 5 second scrub and 3.15% chlorhexidine/70% isopropyl alcohol in people with Bacteremia, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Central Venous Catheter Hubs With Internal Contamination (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.