Central Line-associated Bloodstream Infection (CLABSI)NCT03692559
The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
A study testing full aseptic dressing in people with Central Line-associated Bloodstream Infection (CLABSI), run by National Taiwan University Hospital Hsin-Chu Branch.
Trial summary
The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI)
- What is being tested?
- full aseptic dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2015to 3 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults older than 20 years old
- Patients with central venous catheters
- Agree to participate in this study, and fill out the study consent
Who cannot join
- PICC patients placed
- Patients with bloodstream infection
- Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)
About this study
The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.
Read the detailed description
The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.
- Being tested
- full aseptic dressing
- Keywords
- CRBSI, CLABSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full aseptic dressingOther
Replacement of the central venous catheters in the dressing process
| Study group | Role | What they receive |
|---|---|---|
| full sterile dressing | Experimental | Patients receive full sterile dressing Receives: Other: full aseptic dressing |
| usual standard care | No intervention | Patients receive usual standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related blood stream infections density after dressing change
Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)
Measured: up to 18 months
Secondary outcomes (1)
Central Line-Associated Bloodstream Infection density after dressing change
Confirm blood culture results and judge whether it is catheter related Bloodstream infection, CLABSI
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start20 Aug 2015
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teng,Meng-Lan Head Nurse, National Taiwan University Hospital Hsin-Chu Branch
- Investigators
- Meng-lan Teng, Study chair, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692559
- Sponsor's protocol ID
- 104-032-E
- Status last verified
- Sep 2018
- First submitted
- 18 Oct 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections
- ClinicalTrials.gov ID
- NCT03692559
- Acronym / sponsor ID
- 104-032-E
- Keywords
- CRBSI, CLABSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.
Detailed description
The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full sterile dressing | Experimental | Other: full aseptic dressingPatients receive full sterile dressing |
| usual standard care | No intervention | –Patients receive usual standard care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults older than 20 years old
- Patients with central venous catheters
- Agree to participate in this study, and fill out the study consent
Key exclusion criteria (3 listed)
- PICC patients placed
- Patients with bloodstream infection
- Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)
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 |
|---|---|---|
| full aseptic dressingReplacement of the central venous catheters in the dressing process | Other | full sterile dressing |
Primary outcome
Catheter-related blood stream infections density after dressing change
Time frame: up to 18 months
Confirm blood culture results and judge whether it is catheter related Bloodstream infection(CRBSI)
1 secondary outcome
Central Line-Associated Bloodstream Infection density after dressing change
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
RecruitingPhase 3
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Central Line Associated Blood Stream Infections (CLABSI)
Not yet recruitingObservational study
Central Line-Associated Bloodstream Infection QI Project
Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Neonatal Catheter Lock for Infection Prevention
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
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.
Meng-lan Teng study chair
National Taiwan University Hospital Hsin-Chu Branch
Questions about this trial
What is this clinical trial studying?
A study testing full aseptic dressing in people with Central Line-associated Bloodstream Infection (CLABSI), run by National Taiwan University Hospital Hsin-Chu Branch.
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 3 inclusion and 3 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Catheter-related blood stream infections density after dressing change (time frame: up to 18 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 2 Oct 2018.