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Clinical Trials/NCT04527341
NCT04527341
Unknown
Not Applicable

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

Shanghai Zhongshan Hospital0 sites500 target enrollmentJanuary 1, 2021
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Shanghai Zhongshan Hospital
Enrollment
500
Primary Endpoint
Incidence of postoperative delirium
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
September 30, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of postoperative delirium

Time Frame: up to 5 days postoperatively

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

Secondary Outcomes

  • Severity of postoperative delirium(up to 5 days postoperatively)
  • duration of postoperative delirium(up to 5 days postoperatively)

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