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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT03950440
- Acronym / sponsor ID
- IPOD-AV / S61710
- Conditions
- Postoperative Delirium, Aortic Valve Stenosis
- Keywords
- Transaortic valve replacement, Surgical aortic valve replacement, TAVR, SAVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Any patient presenting for the indicated surgery in a tertiary university hospital
Key inclusion criteria (4 listed)
- Patients scheduled to undergo elective
- Patient able to read and understand the research materials
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Onset Moment of Postoperative Delirium
Time frame: During the first five postoperative days
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
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
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
Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months
Time frame: 6 months
Assessment of Instrumental Activities of Daily Living During 6-months Interview
Time frame: 6 months postoperatively
Intensive Care Unit (ICU) Length of Stay
Time frame: Until 30 days postoperatively
Hospital Length of Stay
Time frame: Until 30 days postoperatively
Count of Patients Discharged Directly Home
Time frame: Until 30 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34876283Hoogma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Hoogma, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Aortic Valve Stenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.