About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Immediate emergency surgery: intervention performed before the start of the next working day following the decision to operate,
Urgent (relative) emergency surgery: patients not admitted electively for surgery but requiring an intervention during the current hospital stay for medical reasons, and who cannot be discharged without undergoing a definitive procedure
Disqualifiers
Patients requiring preoperative cardiopulmonary resuscitation
Scheduled (elective) surgery
Lack of informed consent
Impaired consciousness at the time of inclusion (defined by a Glasgow Coma Scale score < 15)
Trial design
Single group
Treatments tested in this trial
Phone Calls
Other interventionPhone calls will be made at 3, 6, and 12 months to report quality of life scores (EuroQol EQ 5D-5L) and other postoperative data
Treatment groups
Trial outcomes
Primary outcomes
Quality-Adjusted Life Years (QALYs) according to preoperative frailty status
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.
Secondary outcomes
Postoperative complications
Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.
All-cause mortality
All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
EQ-5D-5L Utility Index
Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set
Dialysis dependence
Dialysis dependence among participants not receiving chronic dialysis before surgery.
Sponsors and contacts
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