CRBSI - Catheter Related Bloodstream InfectionCICC-CSNCT07138690
Complications and Failure of Centrally Inserted Central Catheters in Cardiac Surgical Patients
An observational study of CRBSI - Catheter Related Bloodstream Infection and Central Venous Catheter, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Central venous catheters, or CVCs, are medical devices used to deliver medications and blood products directly into a patient's large veins. They are now an essential part of modern hospital care, but their use comes with potential complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRBSI - Catheter Related Bloodstream Infection, Central Venous Catheter, Catheter Failure
- How many people
- 480 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 10 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery performed at the study site with a ultrasound guided right internal jugular vein centrally inserted central catheter placed in the operating room.
Who may be able to join
- Patients aged >18 years.
- Signed informed consent for contactable patients and those who will be attending the treatment center for follow-up visits.
- Patients undergoing elective or emergency cardiac surgery during the study period.
- Cardiac anesthesiologist performing the procedure with >2 years of experience in cardiac surgery and with >100 ultrasound-guided CICC placement procedures per year.
- Patient with a triple- or quad-lumen CICC placed in the right internal jugular vein.
Who cannot join
- Patients with active endocarditis.
- Patients with preoperative sepsis.
- Patients with infection confirmed by another source.
- Patients under 18 years of age.
- Patients who died within 7 days of surgery.
- Patients with a CICC already in place at the time of surgery.
- Cardiac anesthesiologist with less than 2 years of cardiac surgery experience and/or fewer than 100 procedures per year.
- Patients with a CICC placed in the left IJV, subclavian veins, or femoral veins.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Cardiac ICU - Department of Anesthesia and Intensive Care - Careggi University Hospital
Florence, Italy, 50134
About this study
Official title: A Retrospective, Single-center Observational Study on Ultrasound-guided Centrally Inserted Central Catheters Catheter-related Bloodstream Infection and Catheters Failure in Adult Cardiac Surgical Patients.
Central venous catheters, or CVCs, are medical devices used to deliver medications and blood products directly into a patient's large veins. They are now an essential part of modern hospital care, but their use comes with potential complications.
Two of the most serious and well-studied complications are catheter-related bloodstream infections and catheter-related thrombosis (blood clots). These issues not only pose significant health risks to patients but also increase healthcare costs. Fortunately, the frequency of these complications has been reduced by following universally accepted prevention measures, such as:
Read more
Proper hand hygiene and skin disinfection before insertion
Using an ultrasound to guide the procedure
Applying best practices for ongoing catheter maintenance
Besides infections and blood clots, other complications like accidental displacement, lumen occlusion (blockage), or a suspected infection can lead to the early, or premature, removal of a CVC before the completion of the patient's treatment.
In patients undergoing cardiac surgery, CVCs are vital. They are used for general anesthesia, medication delivery, and continuous monitoring of a patient's heart and circulatory system. Because of this critical role, it's essential to constantly monitor the incidence of CVC-related complications in this patient population.
This single-center, retrospective study will investigate two primary objectives:
The frequency of catheter-related infections in adult patients undergoing cardiac surgery.
The frequency of premature catheter removals, or "catheter failures," in the same patient group.
The findings from this study will help improve the management of CVCs in cardiac surgery patients and reduce and prevent future complications.
Read the detailed description
Over recent decades, numerous studies have examined the long-term complications associated with centrally inserted central catheters (CICCs). Among these, catheter-related bloodstream infections (CRBSIs) have been the most extensively investigated due to their association with increased mortality, prolonged hospital stays, and higher healthcare costs. More recently, premature catheter removal-commonly referred to as catheter failure-has emerged as a frequent yet underexplored complication of CICCs and other vascular access devices (VADs), given its contribution to increased patient risk and healthcare burden.
These findings have informed multiple national and international guidelines for CICC placement and management, resulting in significant advances in the prevention and management of CRBSIs and catheter-related thrombosis (CRT), the major causes of late catheter-related complications.
Currently, ultrasound-guided axillary venous access is considered the preferred central venous access site in intensive care units and, more broadly, in hospitalized patients to reduce CRBSI risk.
In cardiac surgical patients, a CICC is required for the administration of general anesthesia during surgery, as well as for intravenous infusions and medications during the postoperative stay in the intensive care unit and cardiac wards. Traditionally, the right internal jugular vein (IJV) has been favored-likely because it was the most accessible site for central venous cannulation in the pre-ultrasound era.
Current evidence shows that right IJV cannulation is associated with a lower risk of mechanical complications and thrombosis, whereas subclavian or axillary vein (SCV/AV) cannulation is linked to a reduced incidence of CRBSIs. However, SCV/AV access-particularly when performed via blind puncture-carries the risk of pinch-off syndrome and, in rare cases, catheter fracture due to compression between the clavicle and the first rib.
For these reasons, the right IJV remains the preferred site during cardiac surgery, while SCV/AV access may be favored postoperatively to lower infection risk and improve patient comfort.
Several factors specific to cardiac surgery further support the choice of the right IJV. These include the potential need for postoperative pacemaker implantation via the left subclavian vein, possible surgical interruption of the brachiocephalic vein during aortic procedures, the favorable anatomy of the right IJV for passage to the superior vena cava, and the elevated bleeding risk in patients requiring perioperative anticoagulation.
In cardiac surgery, the reported incidence of CRBSIs is 1-5%, comparable to that in ICU patients, while the incidence of catheter failure remains unknown. Given the persistent use of the right IJV in cardiac surgery-despite guidelines favoring axillary access-further research into outcomes associated with the IJV in this patient population is warranted.
A comprehensive investigation into the incidence and risk factors for CRBSIs and catheter failure in cardiac surgical patients is essential to optimize CICC management and improve patient safety.
- Conditions
- CRBSI - Catheter Related Bloodstream Infection, Central Venous Catheter, Catheter Failure, Central Venous Catheter Complications
- Keywords
- catheter failure, CRBSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgical patients | Cardiac surgical patients with ultrasound guided centrally inserted catheter into the internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRBSI
Incidence of catheter related bloodstream infection. No of CRBSI/Total catheters*100. No of CRBSI/1000 catheter days.
Measured: Perioperative
Secondary outcomes (1)
Catheter failure
No of catheters removed (causes:CRBSI, CRT, suspected CRI, catheter malposition, catheter malfunction, accidental dislodgment, site competition)/Total catheters * 100
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for CRBSI - Catheter Related Bloodstream InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Mandarano, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Raffaele Mandarano, MD, MSc, Principal investigator, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138690
- Sponsor's protocol ID
- CEAVC 26787
- Acronym
- CICC-CS
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers, clinicians, or public health authorities conducting ethically approved studies aimed at improving patient care or health outcomes could request the data.
Publications
Rockholt MM, Agrell T, Thorarinsdottir H, Kander T. Sustained low catheter related infection (CRI) incidence in an observational follow-up study of 9924 catheters using automated data scripts as quality assurance for central venous catheter (CVC) management. Infect Prev Pract. 2023 Feb 19;5(2):100273. doi: 10.1016/j.infpip.2023.100273. eCollection 2023 Jun.
PubMed 36926533Takashima M, Schults J, Mihala G, Corley A, Ullman A. Complication and Failures of Central Vascular Access Device in Adult Critical Care Settings. Crit Care Med. 2018 Dec;46(12):1998-2009. doi: 10.1097/CCM.0000000000003370.
PubMed 30095499Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Corley A, Royle RH, Marsh N, Larsen EN, Playford EG, McGrail MR, Runnegar N, Ware RS, Gavin NC, Alexandrou E, Murgo M, Gowardman JR, Regli A, Rickard CM. Incidence and risk factors for central venous access device failure in hospitalized adults: A multivariable analysis of 1892 catheters. J Hosp Med. 2024 Oct;19(10):905-917. doi: 10.1002/jhm.13414. Epub 2024 May 27.
PubMed 38800854Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
PubMed 19489710Brescia F, Pittiruti M, Ostroff M, Spencer TR, Dawson RB. The SIC protocol: A seven-step strategy to minimize complications potentially related to the insertion of centrally inserted central catheters. J Vasc Access. 2023 Mar;24(2):185-190. doi: 10.1177/11297298211036002. Epub 2021 Jul 29.
PubMed 34320856Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28.
PubMed 38284956Prachanpanich N, Morakul S, Kiatmongkolkul N. Effectiveness of securing central venous catheters with topical tissue adhesive in patients undergoing cardiac surgery: a randomized controlled pilot study. BMC Anesthesiol. 2021 Mar 8;21(1):70. doi: 10.1186/s12871-021-01282-0.
PubMed 33685394Greco G, Shi W, Michler RE, Meltzer DO, Ailawadi G, Hohmann SF, Thourani VH, Argenziano M, Alexander JH, Sankovic K, Gupta L, Blackstone EH, Acker MA, Russo MJ, Lee A, Burks SG, Gelijns AC, Bagiella E, Moskowitz AJ, Gardner TJ. Costs associated with health care-associated infections in cardiac surgery. J Am Coll Cardiol. 2015 Jan 6;65(1):15-23. doi: 10.1016/j.jacc.2014.09.079.
PubMed 25572505Vervoort D. Global cardiac surgery: a wake-up call. Eur J Cardiothorac Surg. 2019 May 1;55(5):1022-1023. doi: 10.1093/ejcts/ezy319. No abstract available.
PubMed 30260391O'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. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.
PubMed 10691590Tarricone R, Torbica A, Franzetti F, Rosenthal VD. Hospital costs of central line-associated bloodstream infections and cost-effectiveness of closed vs. open infusion containers. The case of Intensive Care Units in Italy. Cost Eff Resour Alloc. 2010 May 10;8:8. doi: 10.1186/1478-7547-8-8.
PubMed 20459753Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. JAMA. 1994 Apr 6;271(13):1014-6.
PubMed 8139059Pandit P, Sahni AK, Grover N, Dudhat V, Das NK, Biswas AK. Catheter-related blood stream infections: prevalence, risk factors and antimicrobial resistance pattern. Med J Armed Forces India. 2021 Jan;77(1):38-45. doi: 10.1016/j.mjafi.2019.07.002. Epub 2019 Oct 15.
PubMed 33487864
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single-center Observational Study on Ultrasound-guided Centrally Inserted Central Catheters Catheter-related Bloodstream Infection and Catheters Failure in Adult Cardiac Surgical Patients.
- ClinicalTrials.gov ID
- NCT07138690
- Acronym / sponsor ID
- CICC-CS / CEAVC 26787
- Conditions
- CRBSI - Catheter Related Bloodstream Infection, Central Venous Catheter, Catheter Failure, Central Venous Catheter Complications
- Keywords
- catheter failure, CRBSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 24 Aug 2025 (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.
Central venous catheters, or CVCs, are medical devices used to deliver medications and blood products directly into a patient's large veins. They are now an essential part of modern hospital care, but their use comes with potential complications.
Two of the most serious and well-studied complications are catheter-related bloodstream infections and catheter-related thrombosis (blood clots). These issues not only pose significant health risks to patients but also increase healthcare costs. Fortunately, the frequency of these complications has been reduced by following universally accepted prevention measures, such as:
Proper hand hygiene and skin disinfection before insertion
Using an ultrasound to guide the procedure
Applying best practices for ongoing catheter maintenance
Besides infections and blood clots, other complications like accidental displacement, lumen occlusion (blockage), or a suspected infection can lead to the early, or premature, removal of a CVC before the completion of the patient's treatment.
In patients undergoing cardiac surgery, CVCs are vital. They are used for general anesthesia, medication delivery, and continuous monitoring of a patient's heart and circulatory system. Because of this critical role, it's essential to constantly monitor the incidence of CVC-related complications in this patient population.
This single-center, retrospective study will investigate two primary objectives:
The frequency of catheter-related infections in adult patients undergoing cardiac surgery.
The frequency of premature catheter removals, or "catheter failures," in the same patient group.
The findings from this study will help improve the management of CVCs in cardiac surgery patients and reduce and prevent future complications.
Detailed description
Over recent decades, numerous studies have examined the long-term complications associated with centrally inserted central catheters (CICCs). Among these, catheter-related bloodstream infections (CRBSIs) have been the most extensively investigated due to their association with increased mortality, prolonged hospital stays, and higher healthcare costs. More recently, premature catheter removal-commonly referred to as catheter failure-has emerged as a frequent yet underexplored complication of CICCs and other vascular access devices (VADs), given its contribution to increased patient risk and healthcare burden.
These findings have informed multiple national and international guidelines for CICC placement and management, resulting in significant advances in the prevention and management of CRBSIs and catheter-related thrombosis (CRT), the major causes of late catheter-related complications.
Currently, ultrasound-guided axillary venous access is considered the preferred central venous access site in intensive care units and, more broadly, in hospitalized patients to reduce CRBSI risk.
In cardiac surgical patients, a CICC is required for the administration of general anesthesia during surgery, as well as for intravenous infusions and medications during the postoperative stay in the intensive care unit and cardiac wards. Traditionally, the right internal jugular vein (IJV) has been favored-likely because it was the most accessible site for central venous cannulation in the pre-ultrasound era.
Current evidence shows that right IJV cannulation is associated with a lower risk of mechanical complications and thrombosis, whereas subclavian or axillary vein (SCV/AV) cannulation is linked to a reduced incidence of CRBSIs. However, SCV/AV access-particularly when performed via blind puncture-carries the risk of pinch-off syndrome and, in rare cases, catheter fracture due to compression between the clavicle and the first rib.
For these reasons, the right IJV remains the preferred site during cardiac surgery, while SCV/AV access may be favored postoperatively to lower infection risk and improve patient comfort.
Several factors specific to cardiac surgery further support the choice of the right IJV. These include the potential need for postoperative pacemaker implantation via the left subclavian vein, possible surgical interruption of the brachiocephalic vein during aortic procedures, the favorable anatomy of the right IJV for passage to the superior vena cava, and the elevated bleeding risk in patients requiring perioperative anticoagulation.
In cardiac surgery, the reported incidence of CRBSIs is 1-5%, comparable to that in ICU patients, while the incidence of catheter failure remains unknown. Given the persistent use of the right IJV in cardiac surgery-despite guidelines favoring axillary access-further research into outcomes associated with the IJV in this patient population is warranted.
A comprehensive investigation into the incidence and risk factors for CRBSIs and catheter failure in cardiac surgical patients is essential to optimize CICC management and improve patient safety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgical patients | – | –Cardiac surgical patients with ultrasound guided centrally inserted catheter into the internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery performed at the study site with a ultrasound guided right internal jugular vein centrally inserted central catheter placed in the operating room.
Key inclusion criteria (5 listed)
- Patients aged >18 years.
- Signed informed consent for contactable patients and those who will be attending the treatment center for follow-up visits.
- Patients undergoing elective or emergency cardiac surgery during the study period.
- Cardiac anesthesiologist performing the procedure with >2 years of experience in cardiac surgery and with >100 ultrasound-guided CICC placement procedures per year.
- Patient with a triple- or quad-lumen CICC placed in the right internal jugular vein.
Key exclusion criteria (8 listed)
- Patients with active endocarditis.
- Patients with preoperative sepsis.
- Patients with infection confirmed by another source.
- Patients under 18 years of age.
- Patients who died within 7 days of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CRBSI
Time frame: Perioperative
Incidence of catheter related bloodstream infection. No of CRBSI/Total catheters*100. No of CRBSI/1000 catheter days.
1 secondary outcome
Catheter failure
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 36926533Rockholt MM, Agrell T, Thorarinsdottir H, Kander T. Sustained low catheter related infection (CRI) incidence in an observational follow-up study of 9924 catheters using automated data scripts as quality assurance for central venous catheter (CVC) management. Infect Prev Pract. 2023 Feb 19;5(2):100273. doi: 10.1016/j.infpip.2023.100273. eCollection 2023 Jun.
- Background: PubMed 30095499Takashima M, Schults J, Mihala G, Corley A, Ullman A. Complication and Failures of Central Vascular Access Device in Adult Critical Care Settings. Crit Care Med. 2018 Dec;46(12):1998-2009. doi: 10.1097/CCM.0000000000003370.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 38800854Corley A, Royle RH, Marsh N, Larsen EN, Playford EG, McGrail MR, Runnegar N, Ware RS, Gavin NC, Alexandrou E, Murgo M, Gowardman JR, Regli A, Rickard CM. Incidence and risk factors for central venous access device failure in hospitalized adults: A multivariable analysis of 1892 catheters. J Hosp Med. 2024 Oct;19(10):905-917. doi: 10.1002/jhm.13414. Epub 2024 May 27.
- Background: PubMed 19489710Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
- Background: PubMed 34320856Brescia F, Pittiruti M, Ostroff M, Spencer TR, Dawson RB. The SIC protocol: A seven-step strategy to minimize complications potentially related to the insertion of centrally inserted central catheters. J Vasc Access. 2023 Mar;24(2):185-190. doi: 10.1177/11297298211036002. Epub 2021 Jul 29.
- Background: PubMed 38284956Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28.
- Background: PubMed 33685394Prachanpanich N, Morakul S, Kiatmongkolkul N. Effectiveness of securing central venous catheters with topical tissue adhesive in patients undergoing cardiac surgery: a randomized controlled pilot study. BMC Anesthesiol. 2021 Mar 8;21(1):70. doi: 10.1186/s12871-021-01282-0.
- Background: PubMed 25572505Greco G, Shi W, Michler RE, Meltzer DO, Ailawadi G, Hohmann SF, Thourani VH, Argenziano M, Alexander JH, Sankovic K, Gupta L, Blackstone EH, Acker MA, Russo MJ, Lee A, Burks SG, Gelijns AC, Bagiella E, Moskowitz AJ, Gardner TJ. Costs associated with health care-associated infections in cardiac surgery. J Am Coll Cardiol. 2015 Jan 6;65(1):15-23. doi: 10.1016/j.jacc.2014.09.079.
- Background: PubMed 30260391Vervoort D. Global cardiac surgery: a wake-up call. Eur J Cardiothorac Surg. 2019 May 1;55(5):1022-1023. doi: 10.1093/ejcts/ezy319. No abstract available.
- Background: PubMed 21511081O'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. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- Background: PubMed 10691590Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.
- Individual participant dataSharing planned: Undecided. Researchers, clinicians, or public health authorities conducting ethically approved studies aimed at improving patient care or health outcomes could request the data.
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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. This study is not recruiting at the moment.
Raffaele Mandarano, MD, MSc principal investigator
Azienda Ospedaliero-Universitaria Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRBSI - Catheter Related Bloodstream Infection and Central Venous Catheter, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Sep 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRBSI (time frame: Perioperative). 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 NCT07138690, which also lists 16 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 3 Sep 2025.