Understanding frailty in patients undergoing heart and vascular surgery
Complexity and Frailty in Cardiothoracic and Vascular Anesthesia (CAfCA). Prospective Multicentric Observational Study
This study looks at how frailty affects older patients having heart and vascular surgeries to see if it can help predict their recovery and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 8 sites (Rozzano, Lombardia and 7 other locations) |
| Trial ID | NCT05968456 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize patients undergoing anesthesia for cardiothoracic and vascular surgeries, focusing on the elements of frailty and associated comorbidities. It highlights the significant impact of frailty on postoperative outcomes, particularly in older populations, and seeks to gather data that can help predict adverse events. By analyzing the prevalence and severity of frailty in surgical patients, the study aims to improve understanding of how frailty influences surgical outcomes and patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 or older who are scheduled for elective cardiac, thoracic, or vascular surgery.
Not a fit: Patients undergoing emergency surgeries or one-day procedures, or those not involving anesthesiologists, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for frail patients undergoing surgery, potentially improving their postoperative outcomes.
How similar studies have performed: Other studies have shown a significant association between frailty and adverse surgical outcomes, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective cardiac, thoracic or vascular surgery * Patients aged 18 or older * Patients who have provided informed consent to participate in the study. Exclusion Criteria: * Patients subjected to surgery in urgency and emergency settings * Procedures in one-day surgery settings * Procedures without the involvement of anesthesiologists
Where this trial is running
Rozzano, Lombardia and 7 other locations
- Istituto Clinico Humanitas — Rozzano, Lombardia, Italy (Completed)
- Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- ASST Ovest Milanese — Legnano, Italy (Completed)
- Fondazione IRCCS Policlinico S. Matteo — Pavia, Italy (Completed)
- AOR San Carlo — Potenza, Italy (Completed)
- Azienda Ospedaliero Universitaria Senese — Siena, Italy (Completed)
- Azienda Ospedaliera Umberto I Mauriziano — Turin, Italy (Recruiting)
- Città della salute e della Scienza di Torino — Turin, Italy (Recruiting)
Study contacts
- Principal investigator: Federico Piccioni, Dr — Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study coordinator: Federico Piccioni, Dr
- Email: federico.piccioni@humanitas.it
- Phone: 0282244151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.