Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT07255105
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiological Investigation of Central Venous Catheter-related Bloodstream Infections in Icus in China
Sponsor:
Jianfeng Xie
Organization:
Study Overview
Official Title:
The First Phase of the Closed-loop Improvement Project for Preventing CLABSI
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: