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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.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

75

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Felipe H Salech, MD PhD
  • 电话号码:+56998739448
  • 邮箱:fhsalech@gmail.com

学习地点

      • Santiago、智利
        • Clinica Bicentenario Red Salud
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Frailty
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Up to 12 months after hospital discharge.
All-cause mortality.
Up to 12 months after hospital discharge.

次要结果测量

结果测量
措施说明
大体时间
Growth Differentiation Factor 15 (GDF-15)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年8月22日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月28日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • P-42.2025

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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