CRBSI - Catheter Related Bloodstream InfectionNCT06085690
Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science
A study testing evidence-based intervention Plan for the Prevention of CRBSI in ICU patients in people with CRBSI - Catheter Related Bloodstream Infection and Evidence-based Nursing Practice, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CRBSI - Catheter Related Bloodstream Infection, Evidence-based Nursing Practice, Central Venous Catheter Related Bloodstream Infection
- What is being tested?
- evidence-based intervention Plan for the Prevention of CRBSI in ICU patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,050 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ICU stay over 48 hours
- CVC was placed for more than 24 hours
Who cannot join
- Pregnant patients
- Patients with a history of CRBSI infection
- Patients with central venous catheterization were brought in from other hospitals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
YuXia Zhang contact
China1 site, 1 recruiting
- Recruiting
ZhongShan Hospital Affilicated to Fudan University
Shanghai, Shanghai Municipality, 200032
CHUNLEI Li, 15800488689, 21211170023@m.fudan.edu.cn
Yuxia Zhang
About this study
Official title: A Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science in China
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:
Read more
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?
Read the 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.
- 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
- Being tested
- evidence-based intervention Plan for the Prevention of CRBSI in ICU patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence-based intervention Plan for the Prevention of CRBSI in ICU patientsBehavioural
On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: evidence-based intervention Plan for the Prevention of CRBSI in ICU patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CRBSI
Measured: 1year
CRBSI incidence ratio
Ratio of CRBSI incidence per quarter (IRR)
Measured: 1 year
Secondary outcomes (3)
Length of ICU stay
Length of ICU stay
Measured: 1 year
Related Mortality
ICU CRBSI-related mortality
Measured: 1 year
ICU hospitalization cost
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start4 Sep 2023
- Primary completion30 Sep 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for CRBSI - Catheter Related Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University Evidence-based Nursing Center, Shanghai Zhongshan Hospital, Children's Hospital of Fudan University, Shanghai Public Health Clinical Center, Shandong First Medical University, Affiliated Hospital of Nantong University, Hospital of Obstetrics and Gynecology affiliated to Fudan University, Shengjing Hospital, The First Affiliated Hospital of University of South China, East China Hospital Affiliated to Fudan University, The First Affiliated Hospital of Dali University, Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chinese Academy of Medical Sciences, Shanghai Minhang Central Hospital, Xi 'an children's hospital, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital Of Guizhou Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen Third People's Hospital, Shanghai Dongfang Hospital
- Responsible party
- Principal investigator, ChunLei Li, Fudan University
- Investigators
- Yan Hu, Study chair, School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan UniversityYuXia Zhang, Study director, Department of Nursing, Zhongshan Hospital Affiliated to Fudan UniversityYing Gu, Study director, Center for Evidence-based Nursing, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085690
- Sponsor's protocol ID
- B2023-212R
- Status last verified
- Oct 2025
- First submitted
- 10 Oct 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research institute shares research data and results according to the plan. The materials and data involved in the study are for the research group only. The final interpretation belongs to the research group
Publications
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.
PubMed 23265289Lindgren 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.
PubMed 24102163Govindan 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.
PubMed 33652363Parienti 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.
PubMed 26398070O'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.
PubMed 21460264Rosenthal 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.
PubMed 25179325Granger 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.
PubMed 29875118Koczwara 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.
PubMed 29750579Pronovost 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.
PubMed 17192537Berenholtz 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.
PubMed 24334799Marsteller 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.
PubMed 22890251Blot 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.
PubMed 24723276Gorski LA. The 2016 Infusion Therapy Standards of Practice. Home Healthc Now. 2017 Jan;35(1):10-18. doi: 10.1097/NHH.0000000000000481.
PubMed 27922994Septimus 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.
PubMed 37260268Zhou 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.
PubMed 40125637
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science in China
- ClinicalTrials.gov ID
- NCT06085690
- Acronym / sponsor ID
- B2023-212R
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,050 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University Evidence-based Nursing Center, Shanghai Zhongshan Hospital, Children's Hospital of Fudan University, Shanghai Public Health Clinical Center, Shandong First Medical University, Affiliated Hospital of Nantong University, Hospital of Obstetrics and Gynecology affiliated to Fudan University, Shengjing Hospital, The First Affiliated Hospital of University of South China, East China Hospital Affiliated to Fudan University, The First Affiliated Hospital of Dali University, Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Chinese Academy of Medical Sciences, Shanghai Minhang Central Hospital, Xi 'an children's hospital, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital Of Guizhou Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen Third People's Hospital, Shanghai Dongfang Hospital
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: evidence-based intervention Plan for the Prevention of CRBSI in ICU patientsOn the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ICU stay over 48 hours
- CVC was placed for more than 24 hours
Key exclusion criteria (3 listed)
- Pregnant patients
- Patients with a history of CRBSI infection
- Patients with central venous catheterization were brought in from other hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evidence-based intervention Plan for the Prevention of CRBSI in ICU patientsOn the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention. | Behavioural | evidence-based intervention Plan for the Prevention of CRBSI in ICU patients |
Primary outcome
Incidence of CRBSI
Time frame: 1year
CRBSI incidence ratio
Time frame: 1 year
Ratio of CRBSI incidence per quarter (IRR)
3 secondary outcomes
Length of ICU stay
Time frame: 1 year
Related Mortality
Time frame: 1 year
ICU hospitalization cost
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 23265289Peng 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.
- Results publication: PubMed 24102163Lindgren 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.
- Results publication: PubMed 33652363Govindan 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.
- Results publication: PubMed 26398070Parienti 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.
- Results publication: PubMed 21460264O'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.
- Results publication: PubMed 25179325Rosenthal 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.
- Results publication: PubMed 29875118Granger 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.
- Results publication: PubMed 29750579Koczwara 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.
- Results publication: PubMed 17192537Pronovost 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.
- Results publication: PubMed 24334799Berenholtz 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.
- Results publication: PubMed 22890251Marsteller 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.
- Results publication: PubMed 24723276Blot 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.
- Individual participant dataSharing planned: Yes. The research institute shares research data and results according to the plan. The materials and data involved in the study are for the research group only. The final interpretation belongs to the research group
Related trials for CRBSI - Catheter Related Bloodstream Infection
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Neonatal Catheter Lock for Infection Prevention
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Enrolling by invitation
Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial
Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YuXia Zhang contact
Yan Hu study chair
School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University
YuXia Zhang study director
Department of Nursing, Zhongshan Hospital Affiliated to Fudan University
Ying Gu study director
Center for Evidence-based Nursing, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evidence-based intervention Plan for the Prevention of CRBSI in ICU patients in people with CRBSI - Catheter Related Bloodstream Infection and Evidence-based Nursing Practice, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHUNLEI Li (15800488689, 21211170023@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CRBSI (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085690, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.