Prediction Model of Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery

NCT05972057 | Unknown

• 1 other identifier: PPSB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by reduced awareness and responsiveness to the environment, as well as orientation disorders, incoherent thinking and memory disorders. Delirium indicates poor recovery of cognitive function, decreased ability of daily life, may need to enter nursing homes, and even lead to adverse outcomes such as death. According to a number of clinical studies, middle-aged and elderly people are prone to delirium after undergoing major surgery. Delirium occurs in 31 % -40 % of patients over 50 years old after cardiac surgery. Compared with patients without postoperative delirium, patients with postoperative delirium had significant cognitive impairment within 1 year after cardiac surgery. The occurrence of delirium suggests that the patient 's brain has become fragile, cognitive function has begun to decline, and the risk of future dementia has increased. Secondly, delirium and dementia have overlapping clinical features and common pathogenic mechanisms. Some scholars even speculate that delirium and dementia represent different stages of a common process. It is generally believed that the peripheral immune system may be involved in the pathogenesis and progression of dementia through the dysfunctional blood-brain barrier. The activation of microglia and astrocytes leads to the release of chemokines, which can recruit peripheral immune cells to the central nervous system. At the same time, cytokines released by peripheral cells can cross the blood-brain barrier and act on glial cells to change their phenotype. This study is a prospective cohort study of patients aged 65 and over who are about to undergo elective cardiac surgery.CyTOF can achieve accurate immunophenotyping of cell populations while comprehensively and accurately detecting and analyzing cytokines and signaling pathways. Therefore, the detection of peripheral blood biomarkers may effectively predict the risk of long-term cognitive dysfunction and postoperative delirium in patients undergoing cardiac surgery.

Conditions

Delirium; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  To establish a risk factor prediction model for postoperative delirium in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.

  up to 5 days after surgery

Secondary Outcomes (1)

• long-term cognitive dysfunction

  1 year after surgery

Interventions

cardiac surgery PROCEDURE

All cardiac surgery patients who met the inclusion criteria were included in the cardiac surgery department of Renji Hospital.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During the implementation of the project, all patients with cardiac surgery who met the inclusion criteria were included in the Department of Cardiac Surgery of Renji Hospital. The total sample size was the sum of all patients by the project deadline.

You may qualify if:

• Age ≥ 65 years
• Patients undergoing elective cardiac surgery with cardiopulmonary bypass
• Sign informed consent

You may not qualify if:

• serious dementia, encephalopathy, mental illness or other neurological diseases
• Patients who could not take neurocognitive tests due to other reasons ( such as language, hearing or visual impairment )
• Patients with stage 3 or 4 malignant tumors, and patients with pancreatic cancer, gallbladder cancer, cholangiocarcinoma and other tumors with high malignancy and expected survival time less than 1 year
• American Society of Anesthesiologists ( ASA ) classification IV or V patients

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Central Study Contacts

Li Peiying, Ph.D.

CONTACT

+8615800616866; peiyingli.md@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 30, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CN (1)