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Multicenter Clinical Translational Study of ICU-NO CRBSI Based on Improvement Science

A Multicenter Clinical Translational Study of ICU-NO CRBSI Based on Improvement Science in China

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085690
Enrollment
8050
Registered
2023-10-17
Start date
2023-09-04
Completion date
2025-12-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Line Infection, Central Venous Catheter Associated Bloodstream Infection, Central Venous Catheter Related Bloodstream Infection, CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Evidence-based Nursing Practice, Quality Improvement

Brief summary

The goal of this type of study is to construct the continuous quality promotion project ICU-NO CRBSI(Catheter-Related Bloodstream Infection , CRBSI) based on improvement science, and to verify its effect in the prevention of central venous catheter-related bloodstream infection and continuous quality improvement in ICU ( Intensive Care Unit , ICU) through multi-center implementation and two rounds of improvement. The main question\[s\] it aims to answer are: What is the incidence of catheter-related bloodstream infection in the ICU of participating units? How compliant are health care providers in the ICU with evidence-based sensory control practices for the prevention of catheter-associated bloodstream infection? Participants will be provided with the hospital's routine CVC (Central Venous Catheter ,CVC) care practices and CVC quality improvement measures based on evidence-based guidelines What technical and cultural support is needed to implement quality and safety improvement measures?

Detailed description

A multicenter, cluster-randomized controlled trial was conducted to verify the effect of the intervention scheme and the improvement strategy. A continuous sample was taken based on subjects that met the inclusion criteria. This study was a multicenter cluster randomized controlled trial involving 23 research centers/medical institutions, including the Evidence-Based Nursing Center of Fudan University and Zhongshan Hospital affiliated to Fudan University. Co-led by the Pediatric Hospital Affiliated to Fudan University, a total of 23,000 catheter days (about 8050 people) were included, and each center planned to include 1,000 catheter days (about 350 people). Patients admitted to ICU from October to December 2023 were taken as baseline study objects, and ICU patients from January to March 2024 were entered into the control phase of the study experiment. ICU patients from April 2024 to June 2024 were included in the continuous observation group, and from July 2024 to September 2024 were included in the continuous observation period. According to the study design characteristics, the intervention will be performed on the control group after the randomized controlled trial phase and the sustainability of the initial intervention group after 3 months will be assessed. The intervention group started in January 2024, implemented the validated intervention protocol and quality promotion implementation strategy, and entered the second phase three months later (April 2024), and the control group became the second intervention group after the intervention in April 2024. In Phase I (the randomized controlled trial phase, January 2024 to March 2024), the effect of the intervention and the improvement strategy was examined by comparing the change in BSI at baseline between the two groups. The control group started the intervention (January 2024) and began reporting bloodstream infection data. In the second phase (April 2024 to June 2024), both groups received the intervention and were followed up until September 2024. Therefore, it is possible to observe the first intervention group for 9 months and also to verify whether the results of the second intervention group (the phase I control group) can be replicated. Control group: According to hospital catheterization, maintenance and central venous catheter extraction routine care. Intervention group: On the basis of routine care, the evidence-based intervention Program for the Prevention of Catheter Related bloodstream infection (CRBSI) in ICU patients was implemented for intervention. Primary outcome: incidence of CRBSI, ratio of CRBSI incidence (quarterly comparison) Secondary outcome :length of stay in ICU, BSI-related mortality in ICU, hospitalization cost in ICU, knowledge and practice score of adherence to evidence-based sensory control in ICU, adherence to evidence-based practice of central venous catheter placement, maintenance and extubation.

Interventions

BEHAVIORALevidence-based intervention Plan for the Prevention of CRBSI in ICU patients

On the basis of routine nursing, the evidence-based intervention Plan for the Prevention of CRBSI in ICU patients was implemented for intervention.

Sponsors

Fudan University Evidence-based Nursing Center
CollaboratorUNKNOWN
Shanghai Zhongshan Hospital
CollaboratorOTHER
Children's Hospital of Fudan University
CollaboratorOTHER
Shanghai Public Health Clinical Center
CollaboratorOTHER_GOV
Shandong First Medical University affiliated Provincial Hospital
CollaboratorUNKNOWN
Affiliated Hospital of Nantong University
CollaboratorOTHER
Hospital of Obstetrics and Gynecology affiliated to Fudan University
CollaboratorUNKNOWN
Shengjing Hospital
CollaboratorOTHER
The First Affiliated Hospital of University of South China
CollaboratorOTHER
East China Hospital Affiliated to Fudan University
CollaboratorUNKNOWN
The First Affiliated Hospital of Dali University
CollaboratorUNKNOWN
Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital
CollaboratorUNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Chinese Academy of Medical Sciences
CollaboratorOTHER
Shanghai Minhang Central Hospital
CollaboratorOTHER
Xi 'an children's hospital
CollaboratorUNKNOWN
Huashan Hospital
CollaboratorOTHER
The First Affiliated Hospital of Xi 'an Jiaotong University
CollaboratorUNKNOWN
Affiliated Hospital of Guizhou Medical University
CollaboratorUNKNOWN
Affiliated Hospital of Southwest Medical University
CollaboratorOTHER
Shenzhen Third People's Hospital
CollaboratorOTHER
Shanghai Dongfang Hospital
CollaboratorUNKNOWN
Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Hospitals were divided into different groups, and the subjects and effect evaluators were blinded because they could not hide the assignment and the implementers were blinded. The main outcome indicators were laboratory objective indicators of CRBSI diagnosis

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* ICU stay over 48 hours * CVC was placed for more than 24 hours

Exclusion criteria

* Pregnant patients * Patients with a history of CRBSI infection * Patients with central venous catheterization were brought in from other hospitals

Design outcomes

Primary

MeasureTime frameDescription
Incidence of CRBSI1year
CRBSI incidence ratio1 yearRatio of CRBSI incidence per quarter (IRR)

Secondary

MeasureTime frameDescription
Length of ICU stay1 yearLength of ICU stay
Related Mortality1 yearICU CRBSI-related mortality
ICU hospitalization cost1 year

Countries

China

Contacts

Primary ContactCHUNLEI Li
21211170023@m.fudan.edu.cn15800488689
Backup ContactYuXia Zhang
Yuxiazhang@zs-hospital.sh.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026