SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older (SAGE-Heart)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Simon CARRE, MD
- 電話番号：+33 0556795679
- メール：simon.carre@chu-bordeaux.fr
研究場所
-
-
France
-
Bordeaux、France、フランス、33076
- 募集
- University Hospital, Bordeaux
-
コンタクト：
- Simon CARRE, MD
- 電話番号：+33 0556795679
- メール：simon.carre@chu-bordeaux.fr
-
-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Frail group
Patients with Clinical Frailty Score CFS ≥ 4
|
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
|
|
実験的：Non-frail group
Patients with Clinical Frailty Score CFS < 4
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality-Adjusted Life Years (QALYs) according to preoperative frailty status
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative complications
時間枠：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
時間枠：Through Month 12
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All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
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Through Month 12
|
|
EQ-5D-5L Utility Index
時間枠：Baseline, Month 3, Month 6, and Month 12
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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
時間枠：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
時間枠：From ICU admission to ICU discharge (assessed up to Day 28)
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Duration of postoperative ICU stay.
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From ICU admission to ICU discharge (assessed up to Day 28)
|
|
Length of hospital stay
時間枠：From surgery to hospital discharge
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Total postoperative hospital length of stay.
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From surgery to hospital discharge
|
|
Hospital readmissions
時間枠：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
時間枠：Month 3, Month 6, and Month 12
|
Presence of chronic pain related to cardiac surgery.
|
Month 3, Month 6, and Month 12
|
|
Analgesic consumption
時間枠：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
時間枠：Month 3, Month 6, and Month 12
|
Living at home versus institutionalization during follow-up.
|
Month 3, Month 6, and Month 12
|
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EQ-5D-5L visual analogue scale (EQ VAS)
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Simon CARRE, MD、University Hospital, Bordeaux
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CHUBX 2025/040
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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