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

NCT ID: NCT07138690

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-08-10

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cardiac surgical patients

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Raffaele Mandarano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raffaele Mandarano, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Careggi

Locations

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

Florence, Italy, Italy

Countries

Italy

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Other Identifiers

CEAVC 26787

Identifier Type: -

Identifier Source: org_study_id