Postoperative Delirium in Cardiac Surgery ICU

NCT04527341 | Unknown

• 1 other identifier: SKQN2020
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.

Conditions

Delirium

Keywords

postoperative delirium; cardiac surgery; Intensive care unit; risk assessment

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Investigators defined patients have delirium if they had at least one positive screening during ICU stay.

  up to 5 days postoperatively

Secondary Outcomes (2)

• Severity of postoperative delirium

  up to 5 days postoperatively

• duration of postoperative delirium

  up to 5 days postoperatively

Study Arms (1)

cardiac surgery patients in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 18 who are admitted to surgical ICUs after cardiac surgery will be screened for eligibility.

You may qualify if:

• Aged above 18
• Patients after cardiac surgery
• Admitted to ICU after surgery

You may not qualify if:

• Preoperative delirium or dementia patients
• Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
• Undergoing surgery procedures do not require admission to SICU
• Transfer to ICU from wards after surgery

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Delirium; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Study Design

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

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 30, 2022
• Last Updated: August 26, 2020

Record last verified: 2020-08