Complications and Failure of Centrally Inserted Central Catheters in Cardiac Surgical Patients

NCT07138690 | Completed

• 1 other identifier: CEAVC 26787
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

CRBSI - Catheter Related Bloodstream Infection; Central Venous Catheter; Catheter Failure; Central Venous Catheter Complications

Keywords

catheter failure; CRBSI

Outcome Measures

Primary Outcomes (1)

• CRBSI

  Incidence of catheter related bloodstream infection. No of CRBSI/Total catheters\*100. No of CRBSI/1000 catheter days.

  Perioperative

Secondary Outcomes (1)

• Catheter failure

  Perioperative

Study Arms (1)

Cardiac surgical patients

Cardiac surgical patients with ultrasound guided centrally inserted catheter into the internal jugular vein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Cardiac ICU - Department of Anesthesia and Intensive Care - Careggi University Hospital

Florence, Italy, 50134, Italy

Location

Related Publications (16)

• 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.

  PMID: 36926533 BACKGROUND

• Takashima 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.

  PMID: 30095499 BACKGROUND

• Harris 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.

  PMID: 18929686 BACKGROUND

• Corley 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.

  PMID: 38800854 BACKGROUND

• Mermel 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.

  PMID: 19489710 BACKGROUND

• Brescia 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.

  PMID: 34320856 BACKGROUND

• Grant 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.

  PMID: 38284956 BACKGROUND

• Prachanpanich 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.

  PMID: 33685394 BACKGROUND

• Greco 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.

  PMID: 25572505 BACKGROUND

• Vervoort 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.

  PMID: 30260391 BACKGROUND

• 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. 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.

  PMID: 21511081 BACKGROUND

• Mermel 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.

  PMID: 10691590 BACKGROUND

• Tarricone 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.

  PMID: 20459753 BACKGROUND

• Raad 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.

  PMID: 8139059 BACKGROUND

• Pandit 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.

  PMID: 33487864 BACKGROUND

• Kalso E. A short history of central venous catheterization. Acta Anaesthesiol Scand Suppl. 1985;81:7-10. doi: 10.1111/j.1399-6576.1985.tb02313.x.

  PMID: 3909712 BACKGROUND

Study Officials

• Raffaele Mandarano, MD, MSc

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 24, 2025
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: August 10, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

IT (1)