N/A
N=250
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Postoperative Delirium · Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03950440 ↗Enrolled (actual)
250
Serious AEs
29.6%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants With Postoperative Delirium — 13; 41; 45 Participants — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Delirium |
13; 41; 45 | <0.0001 sig |
| SECONDARY Onset Moment of Postoperative Delirium |
4; 3; 4 | — |
| SECONDARY Duration of POD |
4; 3; 4 | — |
| SECONDARY Severity of POD |
6; 5; 5 | — |
| SECONDARY Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days |
31; 22; 20 | — |
| SECONDARY Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months |
32; 21; 18 | — |
| SECONDARY Assessment of Instrumental Activities of Daily Living During 6-months Interview |
8.3; 10.8; 11.1 | — |
| SECONDARY Intensive Care Unit (ICU) Length of Stay |
29; 47; 46 | — |
| SECONDARY Hospital Length of Stay |
4; 8; 10 | — |
| SECONDARY Count of Patients Discharged Directly Home |
71; 47; 55 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo elective
- TAVI
- SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
- Patient able to read and understand the research materials
Exclusion Criteria
- Inability to give informed consent
- Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
- Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)
Data sourced from ClinicalTrials.gov (NCT03950440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.