Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID06085690

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

Led by Fudan University · Updated on 2025-11-17

8050

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

F

Fudan University

Lead Sponsor

F

Fudan University Evidence-based Nursing Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter clinical translational study called "ICU-NO CRBSI" to evaluate continuous quality improvement methods aimed at preventing catheter-related bloodstream infections (CRBSI) in Intensive Care Units (ICUs). The study focuses on measuring the incidence of CRBSI in participating ICUs, assessing healthcare providers' adherence to evidence-based practices, and understanding what support is needed to implement safety improvements. This study is a cluster-randomized controlled trial involving 23 medical centers and approximately 23,000 catheter days from about 8,050 patients. It compares routine central venous catheter (CVC) care with an evidence-based intervention program designed to prevent CRBSI. The study includes a baseline phase, a control phase, and an intervention phase with two rounds of quality improvement and follow-up periods to assess the intervention's impact and sustainability. Participants are ICU patients with CVCs placed for more than 24 hours and stays longer than 48 hours. Researchers collect data on CRBSI incidence, ICU stay length, mortality related to bloodstream infections, hospitalization costs, and adherence to care guidelines. The study monitors outcomes over one year through regular reporting, aiming to verify intervention effects and promote continuous quality improvement in ICUs.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ICU stay over 48 hours
  • Central venous catheter placed for more than 24 hours
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Patients with a history of catheter-related bloodstream infection
  • Patients with central venous catheterization brought in from other hospitals

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 9 months

Participants receive routine care or the evidence-based intervention plan aimed at preventing catheter-related bloodstream infections in ICU patients.

Visits occur throughout ICU stay as per routine care and intervention protocols

Follow-up

Duration - Up to 3 months after treatment phase

Participants are observed to assess the sustainability and effect of the intervention after the active treatment phase.

Ongoing monitoring during ICU stay and data collection visits

Trial Site Locations

Total: 1 location

1

ZhongShan Hospital Affilicated to Fudan University

Shanghai, Shanghai Municipality, China, 200032

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Research Team

C

CHUNLEI Li

Y

YuXia Zhang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

International Nosocomial Infection Control Consortium (INICC) report, data summary of 43 countries for 2007-2012. Device-associated module.

Víctor Daniel Rosenthal, Dennis George Maki, Yatin Mehta...

https://pubmed.ncbi.nlm.nih.gov/25179325