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NCT Number: NCT07793708

Older Adults' Recovery Dynamics After Cardiac Surgery

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.

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Key information

Conditions

Frailty Cardiac Surgery Recovery Pathologic Processes Pathological Conditions, Signs and Symptoms Resilience

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frailty

    Time frame: 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).

  2. Functional status assessed by the Barthel Index

    Time frame: 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.

  3. Functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Index

    Time frame: 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.

  4. Cognitive capacity assessed by the Montreal Cognitive Assessment

    Time frame: 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.

  5. Cognitive capacity assessed by the AD8 Dementia Screening Interview

    Time frame: 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.

  6. Locomotor capacity assessed by the Short Physical Performance Battery

    Time frame: 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.

  7. Psychological capacity assessed by the Patient Health Questionnaire-9

    Time frame: 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.

  8. Vitality assessed by the Mini Nutritional Assessment-Short Form

    Time frame: 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.

  9. Visual capacity assessed by the Integrated Care for Older People vision screening tool

    Time frame: 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.

  10. Hearing capacity assessed by the Integrated Care for Older People hearing screening tool

    Time frame: 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.

  11. Perceived fatigability assessed by the Pittsburgh Fatigability Scale

    Time frame: 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.

  12. Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level questionnaire

    Time frame: 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.

  13. Organ dysfunction severity assessed by the Sequential Organ Failure Assessment score

    Time frame: 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.

  14. Postoperative Delirium

    Time frame: During the first 4 postoperative days

    Presence of postoperative delirium assessed during the immediate postoperative period using standardized clinical criteria.

  15. Survival

    Time frame: Up to 12 months after hospital discharge.

    All-cause mortality.

Secondary outcomes

  1. Growth Differentiation Factor 15 (GDF-15)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Felipe H Salech, MD PhD

CONTACT

[email protected]

+56998739448

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Acronym: ODYSSEY

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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