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

NCT06085690 | Recruiting

• 1 other identifier: B2023-212R
• Study Type: interventional
• Target: 8,050
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of CRBSI

  1year

• CRBSI incidence ratio

  Ratio of CRBSI incidence per quarter (IRR)

  1 year

Secondary Outcomes (3)

• Length of ICU stay

  1 year

• Related Mortality

  1 year

• ICU hospitalization cost

  1 year

Study Arms (2)

Existing central venous catheters in the hospital or ICU maintain routine care procedures

NO INTERVENTION

According to the hospital or ICU catheterization, maintenance and removal of central venous catheter routine care

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

EXPERIMENTAL

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

Behavioral: evidence-based intervention Plan for the Prevention of CRBSI in ICU patients

Interventions

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

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

ZhongShan Hospital Affilicated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (15)

• Peng S, Lu Y. Clinical epidemiology of central venous catheter-related bloodstream infections in an intensive care unit in China. J Crit Care. 2013 Jun;28(3):277-83. doi: 10.1016/j.jcrc.2012.09.007. Epub 2012 Dec 21.

  PMID: 23265289 RESULT

• Lindgren S, Pikwer A, Ricksten SE, Akeson J. Survey of central venous catheterisation practice in Sweden. Acta Anaesthesiol Scand. 2013 Nov;57(10):1237-44. doi: 10.1111/aas.12190. Epub 2013 Sep 16.

  PMID: 24102163 RESULT

• Govindan S, Jobe A, O'Malley ME, Flanders SA, Chopra V. To PICC or not to PICC? A cross-sectional survey of vascular access practices in the ICU. J Crit Care. 2021 Jun;63:98-103. doi: 10.1016/j.jcrc.2021.02.004. Epub 2021 Feb 20.

  PMID: 33652363 RESULT

• Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

  PMID: 26398070 RESULT

• O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.

  PMID: 21460264 RESULT

• Rosenthal VD, Maki DG, Mehta Y, Leblebicioglu H, Memish ZA, Al-Mousa HH, Balkhy H, Hu B, Alvarez-Moreno C, Medeiros EA, Apisarnthanarak A, Raka L, Cuellar LE, Ahmed A, Navoa-Ng JA, El-Kholy AA, Kanj SS, Bat-Erdene I, Duszynska W, Van Truong N, Pazmino LN, See-Lum LC, Fernandez-Hidalgo R, Di-Silvestre G, Zand F, Hlinkova S, Belskiy V, Al-Rahma H, Luque-Torres MT, Bayraktar N, Mitrev Z, Gurskis V, Fisher D, Abu-Khader IB, Berechid K, Rodriguez-Sanchez A, Horhat FG, Requejo-Pino O, Hadjieva N, Ben-Jaballah N, Garcia-Mayorca E, Kushner-Davalos L, Pasic S, Pedrozo-Ortiz LE, Apostolopoulou E, Mejia N, Gamar-Elanbya MO, Jayatilleke K, de Lourdes-Duenas M, Aguirre-Avalos G; International Nosocomial Infection Control Consortium. International Nosocomial Infection Control Consortium (INICC) report, data summary of 43 countries for 2007-2012. Device-associated module. Am J Infect Control. 2014 Sep;42(9):942-56. doi: 10.1016/j.ajic.2014.05.029.

  PMID: 25179325 RESULT

• Granger BB. Science of Improvement Versus Science of Implementation: Integrating Both Into Clinical Inquiry. AACN Adv Crit Care. 2018 Summer;29(2):208-212. doi: 10.4037/aacnacc2018757. No abstract available.

  PMID: 29875118 RESULT

• Koczwara B, Stover AM, Davies L, Davis MM, Fleisher L, Ramanadhan S, Schroeck FR, Zullig LL, Chambers DA, Proctor E. Harnessing the Synergy Between Improvement Science and Implementation Science in Cancer: A Call to Action. J Oncol Pract. 2018 Jun;14(6):335-340. doi: 10.1200/JOP.17.00083. Epub 2018 May 14. No abstract available.

  PMID: 29750579 RESULT

• Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.

  PMID: 17192537 RESULT

• Berenholtz SM, Lubomski LH, Weeks K, Goeschel CA, Marsteller JA, Pham JC, Sawyer MD, Thompson DA, Winters BD, Cosgrove SE, Yang T, Louis TA, Meyer Lucas B, George CT, Watson SR, Albert-Lesher MI, St Andre JR, Combes JR, Bohr D, Hines SC, Battles JB, Pronovost PJ; On the CUSP: Stop BSI program. Eliminating central line-associated bloodstream infections: a national patient safety imperative. Infect Control Hosp Epidemiol. 2014 Jan;35(1):56-62. doi: 10.1086/674384. Epub 2013 Nov 26.

  PMID: 24334799 RESULT

• Marsteller JA, Sexton JB, Hsu YJ, Hsiao CJ, Holzmueller CG, Pronovost PJ, Thompson DA. A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units*. Crit Care Med. 2012 Nov;40(11):2933-9. doi: 10.1097/CCM.0b013e31825fd4d8.

  PMID: 22890251 RESULT

• Blot K, Bergs J, Vogelaers D, Blot S, Vandijck D. Prevention of central line-associated bloodstream infections through quality improvement interventions: a systematic review and meta-analysis. Clin Infect Dis. 2014 Jul 1;59(1):96-105. doi: 10.1093/cid/ciu239. Epub 2014 Apr 9.

  PMID: 24723276 RESULT

• Gorski LA. The 2016 Infusion Therapy Standards of Practice. Home Healthc Now. 2017 Jan;35(1):10-18. doi: 10.1097/NHH.0000000000000481.

  PMID: 27922994 RESULT

• Septimus EJ. Society for Healthcare Epidemiology of America Compendium updates 2022. Curr Opin Infect Dis. 2023 Aug 1;36(4):263-269. doi: 10.1097/QCO.0000000000000926. Epub 2023 Jun 2.

  PMID: 37260268 RESULT

• Zhou T, Li C, Wang Z, Yang M, He X, Hu Y. Evidence-Based Practice in Maintenance of Central Venous Catheters Among Intensive Care Unit Nurses: A Cross-Sectional Multi-Center Study. J Clin Nurs. 2025 Oct;34(10):4351-4365. doi: 10.1111/jocn.17692. Epub 2025 Mar 24.

  PMID: 40125637 DERIVED

Study Officials

• Yan Hu

  School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University

  STUDY CHAIR

• YuXia Zhang

  Department of Nursing, Zhongshan Hospital Affiliated to Fudan University

  STUDY DIRECTOR

• Ying Gu

  Center for Evidence-based Nursing, Fudan University

  STUDY DIRECTOR

Central Study Contacts

CHUNLEI Li

CONTACT

15800488689; 21211170023@m.fudan.edu.cn

YuXia Zhang

CONTACT

Yuxiazhang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: September 4, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The materials and data involved in the study are available for five years from the start of the study to the end of the study, and the results of the study are agreed to be used for the study itself.
• Access Criteria: Provide access to the head of each research branch or PI

Locations

CN (1)