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

NCT06330532 | Completed DMC

• 1 other identifier: 4-2023-1526
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• postoperative all cause mortality

  This study evaluates all-cause mortality within 1 year after surgery

  within 1 year

• major composite morbidity

  within 30days after surgery for major composite morbidity

Secondary Outcomes (2)

• the number of days not in hospital

  90 days

• The number of participants who die

  30 days after surgery

Study Arms (3)

Patients categorized as having no frailty on the frailty item, assessed by four domains

cognitive, emotional, physical, and nutritional.

Patients exhibiting the early signs that may lead to frailty, assessed in four domains

cognitive, emotional, physical, and nutritional.

Patients categorized as having frailty on the frailty item, assessed by four domains

cognitive, emotional, physical, and nutritional.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 65 and older undergoing heart and aortic surgery

You may qualify if:

• 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

You may not qualify if:

• Failed to complete two or more of assessments shown above

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health system, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 1, 2024
• Primary Completion: April 5, 2024
• Study Completion: October 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

KR (1)