CLABSI - Central Line Associated Bloodstream InfectionNCT07255105
Epidemiological Investigation of Central Venous Catheter-related Bloodstream Infections in Icus in China
An observational study of CLABSI - Central Line Associated Bloodstream Infection, run by Jianfeng Xie at 1 site in China.
Trial summary
In recent years, with the rapid advancement of medical technology and the rapid development of critical care medicine, the use of various central venous catheters in icus has been increasing day by day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection
- How many people
- 1,846 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a central venous catheter in the ICU expected to be retained for more than 48 hours
Who may be able to join
- 1. Admitted to the ICU with a central venous catheter placed in place and the expected indwelling time exceeds 48 hours (including newly placed central venous catheters or the continued indwelling of existing qualified central venous catheters)
- 2. Patients aged 18 or above
- 3. Sign the informed consent form
Who cannot join
- Patients who have had a central venous catheter indwelled for more than 24 hours before being admitted to the ICU (and are not going to have it replaced immediately)
- Patients who were re-admitted to the ICU during the study period
- Lactating and pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu
cai chenglong, 17381354871, ccl17381354871@163.com
About this study
Official title: The First Phase of the Closed-loop Improvement Project for Preventing CLABSI
In recent years, with the rapid advancement of medical technology and the rapid development of critical care medicine, the use of various central venous catheters in icus has been increasing day by day. Central venous catheter-related bloodstream infection (CLABSI), as a common catheter complication, preventable nosocomial acquired infections have gradually become a focus of attention in the ICU. Once CLABSI occurs, it often leads to a mortality rate as high as 28% to 30% for patients. Data from our country shows that patients with CLASBI will have their hospital stay extended by 8 to 13 days. The additional cost has increased by 3,500 US dollars.
Therefore, over the years, medical systems both at home and abroad have been committed to the prevention and control of CLABSI. The incidence of CLABSI in icus in the United States in 2020 was 0.87 per thousand catheter days. In 2018, the incidence rate of CLABSI in 79 icus in China was 1.5 per thousand catheter days. All the above incidence rates have decreased significantly compared with previous data.
Read more
During the COVID-19 pandemic in 2020, the global healthcare system faced severe challenges. Particularly, factors such as the aggravation of patients' conditions in icus, the sharp increase in the use of central venous catheters, the shortage of medical staff, and the ineffective implementation of CLABSI prevention measures jointly led to a significant increase in the incidence of CLABSI. The number of CLABSI cases recorded by the US NHSN in the fourth quarter increased by as much as 47%. In response to this crisis, international and domestic authoritative institutions responded promptly: In 2022, the American Society of Epidemiology (SHEA) updated its prevention strategy for CLABSI. In the same year, the National Health Commission of China emphasized in its medical quality improvement goals the need to reduce intravascular catheter-related infections, especially in the field of critical care medicine, and explicitly indicated the need to lower the incidence of CLABSI in icus.
However, at present, there is still no large-scale investigation on the incidence of CLABSI after COVID-19 in Chinese mainland. This is related to the fact that there is no standard data collection and monitoring platform at present, and the judgment standards and capabilities of various medical institutions are inconsistent.
This study took adult patients with central venous catheters in icus across the country as the research subjects. Through a prospective cohort study, the current incidence and related influencing factors of CLABSI were clarified. To provide a basis and reference for further formulating and implementing CLBASI prevention strategies in the future.
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of central venous catheter-related bloodstream infections
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start8 Jun 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,846 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255105
- Sponsor's protocol ID
- 2024ZDSYLL338-P01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the later stage, based on the progress of the research and the actual situation, it will be determined
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Phase of the Closed-loop Improvement Project for Preventing CLABSI
- ClinicalTrials.gov ID
- NCT07255105
- Acronym / sponsor ID
- 2024ZDSYLL338-P01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,846 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
In recent years, with the rapid advancement of medical technology and the rapid development of critical care medicine, the use of various central venous catheters in icus has been increasing day by day. Central venous catheter-related bloodstream infection (CLABSI), as a common catheter complication, preventable nosocomial acquired infections have gradually become a focus of attention in the ICU. Once CLABSI occurs, it often leads to a mortality rate as high as 28% to 30% for patients. Data from our country shows that patients with CLASBI will have their hospital stay extended by 8 to 13 days. The additional cost has increased by 3,500 US dollars.
Therefore, over the years, medical systems both at home and abroad have been committed to the prevention and control of CLABSI. The incidence of CLABSI in icus in the United States in 2020 was 0.87 per thousand catheter days. In 2018, the incidence rate of CLABSI in 79 icus in China was 1.5 per thousand catheter days. All the above incidence rates have decreased significantly compared with previous data.
During the COVID-19 pandemic in 2020, the global healthcare system faced severe challenges. Particularly, factors such as the aggravation of patients' conditions in icus, the sharp increase in the use of central venous catheters, the shortage of medical staff, and the ineffective implementation of CLABSI prevention measures jointly led to a significant increase in the incidence of CLABSI. The number of CLABSI cases recorded by the US NHSN in the fourth quarter increased by as much as 47%. In response to this crisis, international and domestic authoritative institutions responded promptly: In 2022, the American Society of Epidemiology (SHEA) updated its prevention strategy for CLABSI. In the same year, the National Health Commission of China emphasized in its medical quality improvement goals the need to reduce intravascular catheter-related infections, especially in the field of critical care medicine, and explicitly indicated the need to lower the incidence of CLABSI in icus.
However, at present, there is still no large-scale investigation on the incidence of CLABSI after COVID-19 in Chinese mainland. This is related to the fact that there is no standard data collection and monitoring platform at present, and the judgment standards and capabilities of various medical institutions are inconsistent.
This study took adult patients with central venous catheters in icus across the country as the research subjects. Through a prospective cohort study, the current incidence and related influencing factors of CLABSI were clarified. To provide a basis and reference for further formulating and implementing CLBASI prevention strategies in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a central venous catheter in the ICU expected to be retained for more than 48 hours
Key inclusion criteria (3 listed)
- 1. Admitted to the ICU with a central venous catheter placed in place and the expected indwelling time exceeds 48 hours (including newly placed central venous catheters or the continued indwelling of existing qualified central venous catheters)
- 2. Patients aged 18 or above
- 3. Sign the informed consent form
Key exclusion criteria (3 listed)
- Patients who have had a central venous catheter indwelled for more than 24 hours before being admitted to the ICU (and are not going to have it replaced immediately)
- Patients who were re-admitted to the ICU during the study period
- Lactating and pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of central venous catheter-related bloodstream infections
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Online data reporting systemLink provided by the sponsor.
- Individual participant dataSharing planned: No. In the later stage, based on the progress of the research and the actual situation, it will be determined
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLABSI - Central Line Associated Bloodstream Infection, run by Jianfeng Xie at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cai chenglong (17381354871, ccl17381354871@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of central venous catheter-related bloodstream infections (time frame: through study completion, an average of 6 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 28 Nov 2025.