Catheter InfectionNCT04920877
Preventing Central Catheter-Associated Bloodstream Infections
A study testing Infection Prevention in people with Catheter Infection and Catheter Infections Related, run by Abant Izzet Baysal University.
Trial summary
The research is an algorithm study focused on nursing care in order to prevent Central Catheter-Associated Bloodstream Infections in intensive care units. The algorithm prepared with infection control measures related to central catheter care will be applied with intensive care nurses and the effect of the algorithm… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Catheter Infection, Catheter Infections Related
- What is being tested?
- Infection Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2021to 31 Dec 2021
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A central venous catheter was inserted in the intensive care unit or before the intensive care unit admission, and being followed up in the intensive care unit with a central venous catheter.
Who cannot join
- Patients whose central venous catheter was terminated during intensive care follow-up.
About this study
Official title: APPLICATION OF NURSE-FOCUSED ALGORITHM IN INTENSIVE CARE UNITS TO PREVENT CENTRAL CATHETER-RELATED BLOODSTREAM İNFECTİONS
The research is an algorithm study focused on nursing care in order to prevent Central Catheter-Associated Bloodstream Infections in intensive care units. The algorithm prepared with infection control measures related to central catheter care will be applied with intensive care nurses and the effect of the algorithm on central catheter-related bloodstream infections will be examined. In practice, a 20-day preliminary assessment, a three-month intervention period, and a three-month post-intervention planning were made.
Read the detailed description
In the light of literature review and guidelines, intensive care nurses will care for central catheters through an algorithm created with infection control measures.
Nurse-focused algorithm content to prevent central catheter-related bloodstream infections Hand hygiene practice Use of personal protective equipment according to infection control measures Evaluation of the catheter insertion site in terms of redness, swelling, tenderness, discharge, bleeding Use of >0.5% chlorhexidine solution containing 70% alcohol for skin antisepsis at the catheter insertion site (if there is no chlorhexidine, povidone iodine + 70% alcohol solution is used) Changing the transparent, semi-permeable dressings every 5-7 days and gauze dressings every 48 hours for catheter dressing Catheter dressing with aseptic technique Use of sterile, preservative-free saline for flushing and locking in order to ensure the lumen of the catheter.
Aseptic conditions should be observed if the junction of the catheter and the infusion set (Hub) is to be touched.
Keeping the used triple taps closed Changing IV fluid sets and connection tools at appropriate times Daily assessment of CVC requirement The research will be carried out in the 1st, 2nd and 3rd Level Intensive Care Units of Bilecik Training and Research Hospital in Bilecik, Turkey. Infection rates will be compared in the study. In the study, the date of June 2021 will be taken as a preliminary assessment and training time for nurses. July-September 2021 will be the intervention period of the study, and October-December 2021 will be the post-intervention period.
- Conditions
- Catheter Infection, Catheter Infections Related
- Being tested
- Infection Prevention
- Keywords
- Catheter, Algorithms, Sepsis
- Medical subject headings
- Catheter-Related Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infection PreventionOther
Preventing central catheter-related bloodstream infections in intensive care units
| Study group | Role | What they receive |
|---|---|---|
| Central catheter-related bloodstream infection rates in intensive care units | Experimental | Not described Receives: Other: Infection Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate
Central catheter-related bloodstream infection rates in intensive care units
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start4 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter InfectionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients followed with a central catheter in the intensive care unit
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun ACUN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920877
- Sponsor's protocol ID
- AIBU-SBF-AA-01
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLICATION OF NURSE-FOCUSED ALGORITHM IN INTENSIVE CARE UNITS TO PREVENT CENTRAL CATHETER-RELATED BLOODSTREAM İNFECTİONS
- ClinicalTrials.gov ID
- NCT04920877
- Acronym / sponsor ID
- AIBU-SBF-AA-01
- Conditions
- Catheter Infection, Catheter Infections Related
- Keywords
- Catheter, Algorithms, Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Jun 2021 (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 research is an algorithm study focused on nursing care in order to prevent Central Catheter-Associated Bloodstream Infections in intensive care units. The algorithm prepared with infection control measures related to central catheter care will be applied with intensive care nurses and the effect of the algorithm on central catheter-related bloodstream infections will be examined. In practice, a 20-day preliminary assessment, a three-month intervention period, and a three-month post-intervention planning were made.
Detailed description
In the light of literature review and guidelines, intensive care nurses will care for central catheters through an algorithm created with infection control measures.
Nurse-focused algorithm content to prevent central catheter-related bloodstream infections Hand hygiene practice Use of personal protective equipment according to infection control measures Evaluation of the catheter insertion site in terms of redness, swelling, tenderness, discharge, bleeding Use of >0.5% chlorhexidine solution containing 70% alcohol for skin antisepsis at the catheter insertion site (if there is no chlorhexidine, povidone iodine + 70% alcohol solution is used) Changing the transparent, semi-permeable dressings every 5-7 days and gauze dressings every 48 hours for catheter dressing Catheter dressing with aseptic technique Use of sterile, preservative-free saline for flushing and locking in order to ensure the lumen of the catheter.
Aseptic conditions should be observed if the junction of the catheter and the infusion set (Hub) is to be touched.
Keeping the used triple taps closed Changing IV fluid sets and connection tools at appropriate times Daily assessment of CVC requirement The research will be carried out in the 1st, 2nd and 3rd Level Intensive Care Units of Bilecik Training and Research Hospital in Bilecik, Turkey. Infection rates will be compared in the study. In the study, the date of June 2021 will be taken as a preliminary assessment and training time for nurses. July-September 2021 will be the intervention period of the study, and October-December 2021 will be the post-intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients followed with a central catheter in the intensive care unit
| Arm | Type | Receives |
|---|---|---|
| Central catheter-related bloodstream infection rates in intensive care units | Experimental | Other: Infection Prevention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A central venous catheter was inserted in the intensive care unit or before the intensive care unit admission, and being followed up in the intensive care unit with a central venous catheter.
Key exclusion criteria (1 listed)
- Patients whose central venous catheter was terminated during intensive care follow-up.
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 |
|---|---|---|
| Infection PreventionPreventing central catheter-related bloodstream infections in intensive care units | Other | Central catheter-related bloodstream infection rates in intensive care units |
Primary outcome
Infection rate
Time frame: Three months
Central catheter-related bloodstream infection rates in intensive care units
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Infection Prevention in people with Catheter Infection and Catheter Infections Related, run by Abant Izzet Baysal University.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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?
Results are not available in the source record.
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?
Infection rate (time frame: Three 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 10 Jun 2021.