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Completed

NCT Number: NCT03950440

Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement

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).

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Key information

Conditions

Postoperative Delirium Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Confusion Delirium Emergence Delirium Heart Diseases Heart Valve Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ventricular Outflow Obstruction

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Participants With Postoperative Delirium

    Time frame: 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.

    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

Secondary outcomes

  1. Onset Moment of Postoperative Delirium

    Time frame: During the first five postoperative days

    Moment of onset of POD during the first five postoperative days or until discharge

  2. Duration of POD

    Time frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge

    Duration of delirium in days using the 3D-CAM or ICU-CAM

  3. Severity of POD

    Time frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge

    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).

  4. Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days

    Time frame: Until 30 days postoperatively

    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.

  5. Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months

    Time frame: 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. Assessment of Instrumental Activities of Daily Living During 6-months Interview

    Time frame: 6 months postoperatively

    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).

  7. Intensive Care Unit (ICU) Length of Stay

    Time frame: Until 30 days postoperatively

    Intensive care unit (ICU) length of stay following the procedure

  8. Hospital Length of Stay

    Time frame: Until 30 days postoperatively

    Amount of days hospitalized in the primary center

  9. Count of Patients Discharged Directly Home

    Time frame: Until 30 days postoperatively

    Discharge destination directly after discharge from the hospital back home

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery

Acronym: IPOD-AV

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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