Cardiovascular SurgeryNCT06685263
Development of Perioperative Delirium Prediction Model
An observational study of Cardiovascular Surgery, run by Kubra Gunes.
Trial summary
Postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 770 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 30 May 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In order to be eligible for inclusion in the study, the patient must be at least 18 years of age and must have undergone a surgical procedure on the cardiovascular system. Furthermore, the subject must not have any mental or sensory impairment, psychiatric diagnosis, or be taking medication for this purpose. Furthermore, the patient must not be in a coma, exhibit a RASS score between -3 and +4, and have a GCS score of 10 or above.
Who may be able to join
- Over 18 years old
- Previous cardiovascular surgery
- No mental deficiency and visual and hearing impairment
- Participants' acceptance to participate in the research
- The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)
Who cannot join
- Cardiovascular surgery under emergency conditions
- Being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery
- Serious conditions such as cardiopulmonary resuscitation during surgery
- Alcohol and drug addiction
- Duration of mechanical ventilation exceeding 36 hours
- Dying in the intensive care unit within 24 hours
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nursel Vatansever contact
About this study
Official title: Development of a Perioperative Delirium Prediction Model in Patients Undergoing Cardiovascular Surgery
Postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. The incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. In light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. The objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.
Read the detailed description
Postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. It is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. Accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. A review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. However, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. The objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.
- Conditions
- Cardiovascular Surgery
- Being tested
- Group 1, Group 2
- Keywords
- cardiovascular surgery, delirium, prediction model
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Behavioural
The development group comprises 385 individuals. Following the data collection phase of the development group, the independent risk factors for the onset of delirium will be identified through statistical analysis. A delirium prediction model will then be constructed using the identified risk factors.
Group 2Behavioural
The validation group comprises 385 individuals. The delirium prediction model created using the data from the development group will be validated by testing the data from the validation group. This will enable the evaluation of the model's fit and calibration in predicting delirium.
| Study group | Role | What they receive |
|---|---|---|
| Development group | The development group comprises 385 individuals. Following the data collection process, the independent risk factors for the development of delirium will be identified through statistical analysis. A delirium prediction model will then be developed based on the identified risk factors. Receives: Behavioral: Group 1 | |
| Validation group | The validation group comprises 385 individuals. The delirium prediction model, constructed using the data from the development group, will be validated by testing the data from the validation group. This process will enable the evaluation of the model's suitability and calibration for predicting delirium. Receives: Behavioral: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a delirium risk prediction model
The objective of this study is to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular SurgeryStudies of the same condition, open and under way.
- 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
- 770 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Kubra Gunes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra Gunes, Uludag University
- Investigators
- Nursel Vatansever, Study director, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685263
- Sponsor's protocol ID
- 2024-15/3
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31.
PubMed 19118253Xu Y, Meng Y, Qian X, Wu H, Liu Y, Ji P, Chen H. Prediction model for delirium in patients with cardiovascular surgery: development and validation. J Cardiothorac Surg. 2022 Oct 1;17(1):247. doi: 10.1186/s13019-022-02005-3.
PubMed 36183105
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Perioperative Delirium Prediction Model in Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT06685263
- Acronym / sponsor ID
- 2024-15/3
- Conditions
- Cardiovascular Surgery
- Keywords
- cardiovascular surgery, delirium, prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Kubra GunesUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 12 Nov 2024 (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 is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. The incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. In light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. The objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.
Detailed description
Postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. It is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. Accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. A review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. However, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. The objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development group | – | Behavioral: Group 1The development group comprises 385 individuals. Following the data collection process, the independent risk factors for the development of delirium will be identified through statistical analysis. A delirium prediction model will then be developed based on the identified risk factors. |
| Validation group | – | Behavioral: Group 2The validation group comprises 385 individuals. The delirium prediction model, constructed using the data from the development group, will be validated by testing the data from the validation group. This process will enable the evaluation of the model's suitability and calibration for predicting delirium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In order to be eligible for inclusion in the study, the patient must be at least 18 years of age and must have undergone a surgical procedure on the cardiovascular system. Furthermore, the subject must not have any mental or sensory impairment, psychiatric diagnosis, or be taking medication for this purpose. Furthermore, the patient must not be in a coma, exhibit a RASS score between -3 and +4, and have a GCS score of 10 or above.
Key inclusion criteria (5 listed)
- Over 18 years old
- Previous cardiovascular surgery
- No mental deficiency and visual and hearing impairment
- Participants' acceptance to participate in the research
- The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)
Key exclusion criteria (6 listed)
- Cardiovascular surgery under emergency conditions
- Being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery
- Serious conditions such as cardiopulmonary resuscitation during surgery
- Alcohol and drug addiction
- Duration of mechanical ventilation exceeding 36 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1The development group comprises 385 individuals. Following the data collection phase of the development group, the independent risk factors for the onset of delirium will be identified through statistical analysis. A delirium prediction model will then be constructed using the identified risk factors. | Behavioural | Development group |
| Group 2The validation group comprises 385 individuals. The delirium prediction model created using the data from the development group will be validated by testing the data from the validation group. This will enable the evaluation of the model's fit and calibration in predicting delirium. | Behavioural | Validation group |
Primary outcome
Development of a delirium risk prediction model
Time frame: 1 year
The objective of this study is to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 19118253Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31.
- Background: PubMed 36183105Xu Y, Meng Y, Qian X, Wu H, Liu Y, Ji P, Chen H. Prediction model for delirium in patients with cardiovascular surgery: development and validation. J Cardiothorac Surg. 2022 Oct 1;17(1):247. doi: 10.1186/s13019-022-02005-3.
- 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.
Nursel Vatansever contact
Nursel Vatansever study director
Uludag University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgery, run by Kubra Gunes.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Gunes (05379406215, kubragunes213@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a delirium risk prediction model (time frame: 1 year). 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 NCT06685263, which also lists 2 linked publications.
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 12 Nov 2024.