Postoperative DeliriumIPOD-AVNCT03950440
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
An observational study of Postoperative Delirium and Aortic Valve Stenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium, Aortic Valve Stenosis
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Sep 2018to 9 Jul 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Any patient presenting for the indicated surgery in a tertiary university hospital
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
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).
Read the detailed 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.
- Conditions
- Postoperative Delirium, Aortic Valve Stenosis
- Keywords
- Transaortic valve replacement, Surgical aortic valve replacement, TAVR, SAVR
- Medical subject headings
- Emergence Delirium, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (9)
Onset Moment of Postoperative Delirium
Moment of onset of POD during the first five postoperative days or until discharge
Measured: During the first five postoperative days
Duration of POD
Duration of delirium in days using the 3D-CAM or ICU-CAM
Measured: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
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).
Measured: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
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.
Measured: Until 30 days postoperatively
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.
Measured: 6 months
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).
Measured: 6 months postoperatively
Intensive Care Unit (ICU) Length of Stay
Intensive care unit (ICU) length of stay following the procedure
Measured: Until 30 days postoperatively
Hospital Length of Stay
Amount of days hospitalized in the primary center
Measured: Until 30 days postoperatively
Count of Patients Discharged Directly Home
Discharge destination directly after discharge from the hospital back home
Measured: Until 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start23 Sep 2018
- Primary completion20 Jan 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Danny Hoogma, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Danny Hoogma, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950440
- Sponsor's protocol ID
- S61710
- Acronym
- IPOD-AV
- Status last verified
- May 2022
- First submitted
- 8 May 2019
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 study. J Thorac Cardiovasc Surg. 2023 Jul;166(1):156-166.e6. doi: 10.1016/j.jtcvs.2021.11.023. Epub 2021 Nov 17.
PubMed 34876283