Меню
Идёт набор NCT07677319

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

Без фазы С лечением Frailty Cardiac Surgery QALYs

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Phone Calls.
Кому может быть актуально
Состояния в реестре: Frailty, Cardiac Surgery, QALYs. Базовые параметры: от 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Quality-Adjusted Life Years (QALYs) according to preoperative frailty status [Срок оценки: Month 12]
Вторичные конечные точки (11)
  • Postoperative complications [Срок оценки: From surgery through,Day 28]
  • All-cause mortality [Срок оценки: Through Month 12]
  • EQ-5D-5L Utility Index [Срок оценки: Baseline, Month 3, Month 6, and Month 12]
  • Dialysis dependence [Срок оценки: Month 3, Month 6, and Month 12]
  • Length of intensive care unit stay [Срок оценки: From ICU admission to ICU discharge (assessed up to Day 28)]
  • Length of hospital stay [Срок оценки: From surgery to hospital discharge]
  • Hospital readmissions [Срок оценки: Month 3, Month 6, and Month 12]
  • Chronic postoperative pain [Срок оценки: Month 3, Month 6, and Month 12]
  • Analgesic consumption [Срок оценки: Month 3, Month 6, and Month 12]
  • Living situation [Срок оценки: Month 3, Month 6, and Month 12]
  • EQ-5D-5L visual analogue scale (EQ VAS) [Срок оценки: Baseline, Month 3, Month 6, and Month 12]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • University Hospital, Bordeaux — Bordeaux

Идентификаторы

NCT: NCT07677319 · CHUBX 2025/040

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗