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

29. juni 2026 oppdatert av: University Hospital, Bordeaux
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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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 :

  • Preoperative: During the anesthesia consultation: Calculation of the CFS (frailty assessment = CFS ≥ 4) EuroQoL 5D-5L (quality of life, with the index calculated with the French value set of the EuroQol), and routine care (renal function: urea, creatinine, albumin levels).
  • Postoperative (ICU and hospital): Collection of complication incidence, mortality (all causes and LATA-related).
  • Follow-up (by phone at 3, 6, and 12 months): CFS and EuroQoL scores, prevalence of chronic pain and analgesic use, dialysis dependency, accommodation status, readmission rates, and death date if applicable.

Studietype

Intervensjonell

Registrering (Antatt)

265

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • France
      • Bordeaux, France, Frankrike, 33076
        • Rekruttering
        • University Hospital, Bordeaux
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients aged ≥ 75 years who are affiliated with or beneficiaries of a social security scheme and undergoing emergency cardiac surgery under cardiopulmonary bypass, either immediate or urgent (relative) :

    • 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

Exclusion Criteria:

  • 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)
  • Individuals under legal guardianship or judicial protection
  • Individuals participating in another interventional research protocol

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Frail group
Patients with Clinical Frailty Score CFS ≥ 4
Annen: Phone Calls
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
Eksperimentell: Non-frail group
Patients with Clinical Frailty Score CFS < 4
Annen: Phone Calls
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality-Adjusted Life Years (QALYs) according to preoperative frailty status
Tidsramme: 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.
Month 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative complications
Tidsramme: From surgery through,Day 28
Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.
From surgery through,Day 28
All-cause mortality
Tidsramme: Through Month 12
All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
Through Month 12
EQ-5D-5L Utility Index
Tidsramme: 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
Baseline, Month 3, Month 6, and Month 12
Dialysis dependence
Tidsramme: Month 3, Month 6, and Month 12
Dialysis dependence among participants not receiving chronic dialysis before surgery.
Month 3, Month 6, and Month 12
Length of intensive care unit stay
Tidsramme: From ICU admission to ICU discharge (assessed up to Day 28)
Duration of postoperative ICU stay.
From ICU admission to ICU discharge (assessed up to Day 28)
Length of hospital stay
Tidsramme: From surgery to hospital discharge
Total postoperative hospital length of stay.
From surgery to hospital discharge
Hospital readmissions
Tidsramme: Month 3, Month 6, and Month 12
Number of hospital readmissions since discharge, assessed at each follow-up visit.
Month 3, Month 6, and Month 12
Chronic postoperative pain
Tidsramme: Month 3, Month 6, and Month 12
Presence of chronic pain related to cardiac surgery.
Month 3, Month 6, and Month 12
Analgesic consumption
Tidsramme: Month 3, Month 6, and Month 12
Type of analgesic medication and frequency of use since the previous follow-up assessment.
Month 3, Month 6, and Month 12
Living situation
Tidsramme: Month 3, Month 6, and Month 12
Living at home versus institutionalization during follow-up.
Month 3, Month 6, and Month 12
EQ-5D-5L visual analogue scale (EQ VAS)
Tidsramme: Baseline, Month 3, Month 6, and Month 12
Self-rated health status assessed using the EQ-5D-5L visual analogue scale (0-100).
Baseline, Month 3, Month 6, and Month 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Bordeaux

Etterforskere

  • Hovedetterforsker: Simon CARRE, MD, University Hospital, Bordeaux

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. desember 2025

Primær fullføring (Antatt)

3. desember 2028

Studiet fullført (Antatt)

3. desember 2028

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

30. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHUBX 2025/040

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Nei

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Nei

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