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NCT06330532 Clinical Trial

Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients

Cardiovascular Diseases Clinical Trial

Official title:
Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06330532
Other study ID # 4-2023-1526
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date February 28, 2025

Study information
Verified date March 2024
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Yonsei University Health system, Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
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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