Postoperative Delirium in Cardiac Surgery ICU

Delirium Clinical Trial

Official title:

Study on Visual Assessment System and Stratified Management Program for Postoperative Delirium After Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527341
• Other study ID #: SKQN2020
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged above 18

• Patients after cardiac surgery

• Admitted to ICU after surgery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of postoperative delirium	Assess by CAM-ICU-7 if CAM-ICU is positive. Categorized as no delirium: 0-2, mild to moderate delirium: 3-5, and severe delirium: 6-7	up to 5 days postoperatively
Secondary	duration of postoperative delirium	Defined as time (in days) from the first positive CAM-ICU until the beginning of two consecutive days of negative CAM-ICU.	up to 5 days postoperatively