Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— IPOD-AV  

Official title:

Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950440
• Other study ID #: S61710
• Status: Completed
• Start date: September 23, 2018
• Est. completion date: July 9, 2020

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 9, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Hoogma DF, Venmans E, Al Tmimi L, Tournoy J, Verbrugghe P, Jacobs S, Fieuws S, Milisen K, Adriaenssens T, Dubois C, Rex S. Postoperative delirium and quality of life after transcatheter and surgical aortic valve replacement: A prospective observational st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Postoperative Delirium	Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) and nurse reports combined with interview with the caregivers and patient	Until the fifth postoperative day in hospital (an average of 5 days). In case of POD, followup was continued until resolution of POD or discharge (whichever comes first) up to 19 days.
Secondary	Onset Moment of Postoperative Delirium	Moment of onset of POD during the first five postoperative days or until discharge	During the first five postoperative days
Secondary	Duration of POD	Duration of delirium in days using the 3D-CAM or ICU-CAM	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
Secondary	Severity of POD	assessed with the delirium long severity measure-based confusion assessment method (CAM-S Long). Ten features are evaluated and scored. The first item is either 0 (not present) or 1 (yes). The other 9 features are scored as 0 (not present), 1 (present but mild) or 2 (present and marked). These subscores are than combined on a scale ranging from 0 (no delirium) to 19 (severe delirium).	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
Secondary	Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days	Count of patient having an adverse event according to the composite endpoint "Early safety (at 30 days)" defined by the Valve Academic Research Consortium (VARC)-2. These include: all-cause mortality, all stroke, life threatening bleeding, acute kidney injury stage 2 or 3 and major vascular complications.	Until 30 days postoperatively
Secondary	Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months	Count of patient having an adverse event according to the composite endpoint "Clinical efficacy (at 6 months)" defined by the Valve Academic Research Consortium (VARC)-2. These include: all-cause mortality, all stroke, rehospitalization, NYHA Classe 3 or 4 and valve dysfunction.	6 months
Secondary	Assessment of Instrumental Activities of Daily Living During 6-months Interview	Assessment of Instrumental activities of daily living (IADL) divided over 7 items. Each item can be scored with either 0 (not capable), 1 (capable with aid) or 2 (without aid). These subscores are summed on a scale ranging from 0 (worse outcome) to 14 (best outcome).	6 months postoperatively
Secondary	Intensive Care Unit (ICU) Length of Stay	Intensive care unit (ICU) length of stay following the procedure	Until 30 days postoperatively
Secondary	Hospital Length of Stay	Amount of days hospitalized in the primary center	Until 30 days postoperatively
Secondary	Count of Patients Discharged Directly Home	Discharge destination directly after discharge from the hospital back home	Until 30 days postoperatively