CompletedNot Applicable

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

Italy480 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CRBSI

Timeframe: Perioperative

Trial details

NCT IDNCT07138690

SponsorAzienda Ospedaliero-Universitaria Careggi

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More CRBSI - Catheter Related Bloodstream Infection trials