Cardiovascular Diseases Clinical Trial
Official title:
Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients
Verified date | March 2024 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery.
Status | Active, not recruiting |
Enrollment | 450 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (Clinical Frailty scale, Handgrip strength), cognitive(K-MoCA, K-MMSE), and emotional (SGDS-K) functioning tests at the preoperative interview Exclusion Criteria: - Failed to complete two or more of assessments shown above |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University Health system, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative all cause mortality | This study evaluates all-cause mortality within 1 year after surgery | within 1 year | |
Primary | major composite morbidity | within 30days after surgery for major composite morbidity | ||
Secondary | the number of days not in hospital | DAOH is the number of days not in hospital over a defined postoperative period | 90 days | |
Secondary | The number of participants who die | patients who die | 30 days after surgery |
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