SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity Hospital, Bordeaux

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Phone Calls

    Other intervention

    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

Treatment groups

265 Participants
are divided into 2 treatment groups
Group A: Frail groupExperimental treatment 1 intervention
Group B: Non-frail groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 12

Secondary outcomes

1

Postoperative complications

Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.

Time frame
From surgery through,Day 28
2

All-cause mortality

All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.

Time frame
Through Month 12
3

EQ-5D-5L Utility Index

Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set

Time frame
Baseline, Month 3, Month 6, and Month 12
4

Dialysis dependence

Dialysis dependence among participants not receiving chronic dialysis before surgery.

Time frame
Month 3, Month 6, and Month 12

Other outcomes

Sponsors and contacts

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