Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science
NCT ID: NCT06085690
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8050 participants
INTERVENTIONAL
2023-09-04
2025-12-31
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Existing central venous catheters in the hospital or ICU maintain routine care procedures
According to the hospital or ICU catheterization, maintenance and removal of central venous catheter routine care
No interventions assigned to this group
evidence-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.
evidence-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.
Interventions
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evidence-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.
Eligibility Criteria
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Inclusion Criteria
* CVC was placed for more than 24 hours
Exclusion Criteria
* Patients with a history of CRBSI infection
* Patients with central venous catheterization were brought in from other hospitals
ALL
Yes
Sponsors
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Fudan University Evidence-based Nursing Center
UNKNOWN
Shanghai Zhongshan Hospital
OTHER
Children's Hospital of Fudan University
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
Shandong First Medical University affiliated Provincial Hospital
UNKNOWN
Affiliated Hospital of Nantong University
OTHER
Hospital of Obstetrics and Gynecology affiliated to Fudan University
UNKNOWN
Shengjing Hospital
OTHER
The First Affiliated Hospital of University of South China
OTHER
East China Hospital Affiliated to Fudan University
UNKNOWN
The First Affiliated Hospital of Dali University
UNKNOWN
Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Chinese Academy of Medical Sciences
OTHER
Shanghai Minhang Central Hospital
OTHER
Xi 'an children's hospital
UNKNOWN
Huashan Hospital
OTHER
The First Affiliated Hospital of Xi 'an Jiaotong University
UNKNOWN
Affiliated Hospital of Guizhou Medical University
UNKNOWN
Affiliated Hospital of Southwest Medical University
OTHER
Shenzhen Third People's Hospital
OTHER
Shanghai Dongfang Hospital
UNKNOWN
Fudan University
OTHER
Responsible Party
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ChunLei Li
graduate student
Principal Investigators
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Yan Hu
Role: STUDY_CHAIR
School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University
YuXia Zhang
Role: STUDY_DIRECTOR
Department of Nursing, Zhongshan Hospital Affiliated to Fudan University
Ying Gu
Role: STUDY_DIRECTOR
Center for Evidence-based Nursing, Fudan University
Locations
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ZhongShan Hospital Affilicated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gorski LA. The 2016 Infusion Therapy Standards of Practice. Home Healthc Now. 2017 Jan;35(1):10-18. doi: 10.1097/NHH.0000000000000481.
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.
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.
Other Identifiers
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B2023-212R
Identifier Type: -
Identifier Source: org_study_id
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