Postoperative DeliriumNCT03635229
Risk Factor of POD and POCD After Cardiac Surgery
An observational study of Postoperative Delirium and Postoperative Cognitive Dysfunction, run by Mahidol University at 1 site in Thailand.
Trial summary
Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction
- How many people
- 360 participants
- Where
- 1 siteThailand
- Study dates
- 21 Aug 2018to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients (age 65 and older) undergoing cardiopulmonary bypass- assisted surgery with anticipated postoperative intensive care unit admission
Who may be able to join
- age 65 years old or older
- undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery
Who cannot join
- unable to communicate
- severe visual or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery
Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes.
Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD.
Incidences vary across institutions due to differences in screening and diagnostic tools.
Read the detailed description
This is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (ICU) admission.
Patients will be screen for POD and POCD with various psychological tests in the postoperative period and after hospital discharge.
Perioperative data and outcomes will be used to identify risk factors of both conditions.
- Keywords
- cardiac surgery, perioperative care, postoperative delirium, postoperative cognitive dysfunction
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
Measured: Postoperative day 1-5 (5 consecutive days)
Secondary outcomes (3)
Postoperative cognitive dysfunction - postoperative
A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)
Measured: Postoperative day 5-9 (5 consecutive days)
Postoperative cognitive dysfunction - 3 month
A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)
Measured: At 3rd month after hospital discharge
Postoperative cognitive dysfunction - 1 year
A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)
Measured: At 12th month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start21 Aug 2018
- Primary completion26 Sep 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635229
- Sponsor's protocol ID
- 705/2560(EC1)
- Status last verified
- Oct 2023
- First submitted
- 15 Aug 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03635229
- Acronym / sponsor ID
- 705/2560(EC1)
- Keywords
- cardiac surgery, perioperative care, postoperative delirium, postoperative cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes.
Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD.
Incidences vary across institutions due to differences in screening and diagnostic tools.
Detailed description
This is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (ICU) admission.
Patients will be screen for POD and POCD with various psychological tests in the postoperative period and after hospital discharge.
Perioperative data and outcomes will be used to identify risk factors of both conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients (age 65 and older) undergoing cardiopulmonary bypass- assisted surgery with anticipated postoperative intensive care unit admission
Key inclusion criteria (2 listed)
- age 65 years old or older
- undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery
Key exclusion criteria (2 listed)
- unable to communicate
- severe visual or hearing impairment
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
Postoperative delirium
Time frame: Postoperative day 1-5 (5 consecutive days)
A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
3 secondary outcomes
Postoperative cognitive dysfunction - postoperative
Time frame: Postoperative day 5-9 (5 consecutive days)
Postoperative cognitive dysfunction - 3 month
Time frame: At 3rd month after hospital discharge
Postoperative cognitive dysfunction - 1 year
Time frame: At 12th month after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Cognitive Dysfunction, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Oct 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 Thailand. 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?
Results are not available in the source record.
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?
Postoperative delirium (time frame: Postoperative day 1-5 (5 consecutive days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.