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Older Adults' Recovery Dynamics After Cardiac Surgery (ODYSSEY)

2026年8月26日 更新者:Felipe Salech Morales、University of Chile

Clinical, Functional, and Biological Characterization of Resilience in Older Adults Undergoing Cardiac Surgery: ODYSSEY Study - Pilot Phase

Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Current clinical tools, such as frailty assessments, help identify higher-risk populations but do not adequately explain the marked individual variability in recovery or accurately predict who will develop complications. This variability may be partly explained by individual resilience, defined as the ability to recover toward, return to, or even surpass a prior functional state after an acute stressor. Evidence suggests that biological mechanisms related to aging influence resilience; however, biomarkers and integrated clinical models capable of characterizing and potentially modulating resilience in humans remain limited. Therefore, a standardized clinical platform is needed to characterize physiological resilience and its determinants, generating actionable knowledge to improve risk stratification, guide interventions, and optimize recovery in older adults.

To this end, a single-center prospective cohort study will be conducted at Clinica Bicentenario Santiago, including individuals aged ≥65 years who are independent or have mild dependency and are undergoing elective cardiac surgery requiring sternotomy for valvular and/or coronary artery disease, recruited between 2026 and 2027. Participants will undergo a baseline assessment 2-3 weeks before surgery; an early postoperative assessment focused on the systematic recording of clinical outcomes, including delirium and organ dysfunction; and longitudinal follow-up to characterize recovery after discharge. Follow-up assessments will include frailty, intrinsic capacity (the composite of an individual's physical and mental capacities across the cognitive, locomotor, psychological, vitality, and sensory domains), functional status, health-related quality of life, and perceived fatigability, according to the prespecified assessment schedule.

In addition, blood samples will be collected at three time points (baseline, 24 hours postoperatively, and one month after surgery) to measure plasma levels of growth differentiation factor 15 (GDF-15), a biomarker associated with aging-related biological stress and systemic responses to tissue injury. It is projected that at least 75 participants will be recruited over a 12-month period, allowing characterization of baseline clinical and functional profiles, the frequency of postoperative complications and organ dysfunction, trajectories of recovery, and associations between baseline characteristics, biological markers, and subsequent recovery outcomes.

調査の概要

状態

まだ募集していません

研究の種類

観察的

入学 (推定)

75

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Felipe H Salech, MD PhD
  • 電話番号:+56998739448
  • メール:fhsalech@gmail.com

研究場所

      • Santiago、チリ
        • Clinica Bicentenario Red Salud
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population will consist of adults aged 65 years or older undergoing elective cardiac surgery, recruited between 2025 and 2026 at Clínica Bicentenario, a high-complexity surgical center located in Santiago, Chile.

説明

Inclusion Criteria:

  • Older adults (≥ 65 años) undergoing elective cardiac surgery via median sternotomy, including coronary artery bypass grafting (CABG) and/or valvular surgery.
  • Independence in basic daily activities, defined as a Barthel Index score ≥80.

Exclusion Criteria:

  • Emergency surgery for any indication
  • Terminal illness, defined as a life expectancy of less than 12 months
  • History of cognitive impairment, defined as a documented diagnosis of dementia and/or current treatment with memantine or donepezil
  • Advanced hepatic or renal failure, defined as Child-Pugh class C liver disease or chronic dialysis

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

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
Frailty
時間枠:1 month after discharge
Frailty measured by the Physical Frailty Phenotype (Fried Frailty Phenotype). The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants are classified as robust (score 0), prefrail (score 1-2), or frail (score 3-5).
1 month after discharge
Functional status assessed by the Barthel Index
時間枠:1, 6, and 12 months after discharge
Functional status in basic activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100 points, with higher scores indicating greater independence in basic activities of daily living and therefore better functional status.
1, 6, and 12 months after discharge
Functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Index
時間枠:1, 6, and 12 months after hospital discharge
Functional status in instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Index. The scale evaluates independence in instrumental activities of daily living, with higher scores indicating greater independence and therefore better functional status.
1, 6, and 12 months after hospital discharge
Cognitive capacity assessed by the Montreal Cognitive Assessment
時間枠:1 month after hospital discharge
Cognitive capacity will be assessed using the Montreal Cognitive Assessment (MoCA), a cognitive screening instrument evaluating multiple cognitive domains. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
1 month after hospital discharge
Cognitive capacity assessed by the AD8 Dementia Screening Interview
時間枠:1 month after hospital discharge
Cognitive capacity will also be assessed using the AD8 Dementia Screening Interview (AD8), an 8-item screening instrument for cognitive change. The total score ranges from 0 to 8 points, with higher scores indicating greater cognitive impairment and therefore a worse outcome.
1 month after hospital discharge
Locomotor capacity assessed by the Short Physical Performance Battery
時間枠:1 month after hospital discharge
Locomotor capacity will be assessed using the Short Physical Performance Battery (SPPB), which evaluates standing balance, gait speed, and repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
1 month after hospital discharge
Psychological capacity assessed by the Patient Health Questionnaire-9
時間枠:1 month after hospital discharge
Psychological capacity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item instrument assessing depressive symptoms. The total score ranges from 0 to 27 points, with higher scores indicating greater severity of depressive symptoms and therefore a worse outcome.
1 month after hospital discharge
Vitality assessed by the Mini Nutritional Assessment-Short Form
時間枠:1 month after hospital discharge
Vitality will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF), a nutritional screening instrument for older adults. The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status.
1 month after hospital discharge
Visual capacity assessed by the Integrated Care for Older People vision screening tool
時間枠:1 month after hospital discharge
Visual capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) vision screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of visual impairment or evidence of visual impairment.
1 month after hospital discharge
Hearing capacity assessed by the Integrated Care for Older People hearing screening tool
時間枠:1 month after hospital discharge
Hearing capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) hearing screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of hearing impairment or evidence of hearing impairment.
1 month after hospital discharge
Perceived fatigability assessed by the Pittsburgh Fatigability Scale
時間枠:1 month after hospital discharge
Perceived fatigability will be assessed using the Pittsburgh Fatigability Scale (PFS), which evaluates anticipated physical and mental fatigue associated with 10 standardized activities. Each activity is rated from 0 to 5 points, with 0 indicating no fatigue and 5 indicating extreme fatigue. Physical fatigability and mental fatigability are scored separately, each ranging from 0 to 50 points. Higher scores indicate greater perceived fatigability and therefore a worse outcome.
1 month after hospital discharge
Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level questionnaire
時間枠:1 month after hospital discharge
Health-related quality of life will be assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. The descriptive system evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels: no problems, some or moderate problems, and extreme problems. In addition, participants will rate their overall health using the EuroQol Visual Analogue Scale (EQ VAS), which ranges from 0 to 100, with higher scores indicating better perceived health status.
1 month after hospital discharge
Organ dysfunction severity assessed by the Sequential Organ Failure Assessment score
時間枠:During the first 4 postoperative days
Organ dysfunction severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score, which evaluates respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal function. The total score ranges from 0 to 24 points, with higher scores indicating greater organ dysfunction and therefore a worse outcome.
During the first 4 postoperative days
Postoperative Delirium
時間枠:During the first 4 postoperative days
Presence of postoperative delirium assessed during the immediate postoperative period using standardized clinical criteria.
During the first 4 postoperative days
Survival
時間枠:Up to 12 months after hospital discharge.
All-cause mortality.
Up to 12 months after hospital discharge.

二次結果の測定

結果測定
メジャーの説明
時間枠
Growth Differentiation Factor 15 (GDF-15)
時間枠:24 hours after cardiac surgery and 1 month after hospital discharge
Plasma levels of Growth Differentiation Factor 15 (GDF-15) measured as a biomarker of biological stress and resilience.
24 hours after cardiac surgery and 1 month after hospital discharge

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2029年10月1日

試験登録日

最初に提出

2026年8月22日

QC基準を満たした最初の提出物

2026年8月26日

最初の投稿 (実際)

2026年8月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • P-42.2025

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