University Hospital, Bordeaux
Bordeaux, France, 33076
Location status: Recruiting
NCT Number: NCT07677319
The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.
Interested in participating?
Request Info75 year and older
All sexes
Interventional
Not applicable
Bordeaux, France, 33076
Location status: Recruiting
The advancement of structural cardiology, particularly with percutaneous valve interventions, offers new treatment options without the need for cardiopulmonary bypass (CPB). Despite an increase in the use of these techniques, some studies highlight a notable rise in CPB usage in patients aged 80 and over, from 13.8% in 2013 to 20.5% in 2022. In France, the population aged 85 and above is expected to triple by 2050, meaning more elderly patients will be eligible for CPB cardiac surgery. Several global studies have examined the outcomes of older individuals undergoing CPB cardiac surgery. While EuroSCORE II and STS scores are effective in predicting short-term mortality, they lack accuracy in predicting long-term mortality, particularly in frail patients, and do not assess quality of life. New tools to evaluate frailty, such as the Clinical Frailty Scale (CFS), are now used in preoperative assessments for planned cardiac interventions. Identifying frail elderly patients early is crucial for improving patient and family information on care plans, especially in high-risk surgeries. Even in emergencies, patients must remain involved in their health decisions, and multidisciplinary collaboration is vital for improving postoperative recovery and quality of life.
Data will be collected :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phone calls will be made at 3, 6, and 12 months to report quality of life scores (EuroQol EQ 5D-5L) and other postoperative data
Time frame: Month 12
QALYs over the 12-month follow-up will be estimated from EQ-5D-5L utility scores collected at baseline, Month 3, Month 6, and Month 12 together with survival data, and compared between participants with preoperative frailty (Clinical Frailty Scale ≥4) and those without frailty (Clinical Frailty Scale <4), with adjustment for EuroSCORE II.
Time frame: From surgery through,Day 28
Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.
Time frame: Through Month 12
All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
Time frame: Baseline, Month 3, Month 6, and Month 12
Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set
Time frame: Month 3, Month 6, and Month 12
Dialysis dependence among participants not receiving chronic dialysis before surgery.
Time frame: From ICU admission to ICU discharge (assessed up to Day 28)
Duration of postoperative ICU stay.
Time frame: From surgery to hospital discharge
Total postoperative hospital length of stay.
Time frame: Month 3, Month 6, and Month 12
Number of hospital readmissions since discharge, assessed at each follow-up visit.
Time frame: Month 3, Month 6, and Month 12
Presence of chronic pain related to cardiac surgery.
Time frame: Month 3, Month 6, and Month 12
Type of analgesic medication and frequency of use since the previous follow-up assessment.
Time frame: Month 3, Month 6, and Month 12
Living at home versus institutionalization during follow-up.
Time frame: Baseline, Month 3, Month 6, and Month 12
Self-rated health status assessed using the EQ-5D-5L visual analogue scale (0-100).
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Acronym: SAGE-Heart
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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