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Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement — IPOD-AV  

Aortic Valve Stenosis Clinical Trial

Official title:
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery

Clinical Trial Summary

Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).

Clinical Trial Description

A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03950440
Study type Observational
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Completed
Phase
Start date September 23, 2018
Completion date July 9, 2020
View Details
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