DeliriumNCT05218720
Delirium and EuroSCORE II in Cardiac Surgery
An observational study of Delirium, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this observational study is to find out the association between EuroSCORE II of Delirium in patients undergoing cardiac surgery. The main questions it aims to answer are the incidence of Delirium in patients undergoing cardiac surgery and to find the association of EuroSCORE II with delirium in cardiac… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium
- What is being tested?
- EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 24 May 2024
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients (18-80 years) undergoing elective cardiac surgeries (CABG, MVR, AVR), receiving invasive ventilation
Who may be able to join
- Age greater than or equal to 18 years
- ASA I -IV
- Patients undergoing elective cardiac surgery
Who cannot join
- Patients undergoing emergency cardiac surgeries
- History of stroke in the last 6 weeks
- History of delirium
- History of psychiatric illness
- history of medication for psychiatric illness
- Patients undergoing reopen surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Delirium and EuroSCORE II in Cardiac Surgery Patients
The goal of this observational study is to find out the association between EuroSCORE II of Delirium in patients undergoing cardiac surgery.
The main questions it aims to answer are the incidence of Delirium in patients undergoing cardiac surgery and to find the association of EuroSCORE II with delirium in cardiac surgery patients.
- Conditions
- Delirium
- Being tested
- EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)
- Keywords
- Cardiac Surgery, Post-operative Delirium, Coronary Artery Bypass Grafting, EuroSCORE II
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)Other
- EuroSCORE II is used to predict the risk of in-hospital mortality after cardiac surgery. Where very low risk is <1, low risk is 1-2.99, moderate risk is 3-4.99, and high risk is >5.
- CAM- ICU: The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium in patients in intensive care. The score ranges from 0-. Where 0-2 is no delirium, ≥ 3 is positive for delirium, 3-5 mild delirium, 6-7 severe delirium with 7 considered most severe delirium.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delirium
As per DSM 5 criteria delirium is an acute condition. Symptoms begin over a few hours or a few days. Delirium will be assessed by CAM-ICU score.
Measured: Day 1
Association of Euroscore II Category With Delirium
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Mar 2022
- Primary completion23 May 2023
- Study completion24 May 2024
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 (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Siddiqui, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218720
- Sponsor's protocol ID
- 2021-6153-19008
- Status last verified
- May 2026
- First submitted
- 31 Jan 2022
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Norkiene I, Ringaitiene D, Kuzminskaite V, Sipylaite J. Incidence and risk factors of early delirium after cardiac surgery. Biomed Res Int. 2013;2013:323491. doi: 10.1155/2013/323491. Epub 2013 Sep 12.
PubMed 24102052Norkiene I, Ringaitiene D, Misiuriene I, Samalavicius R, Bubulis R, Baublys A, Uzdavinys G. Incidence and precipitating factors of delirium after coronary artery bypass grafting. Scand Cardiovasc J. 2007 Jun;41(3):180-5. doi: 10.1080/14017430701302490.
PubMed 17487768Koster S, Oosterveld FG, Hensens AG, Wijma A, van der Palen J. Delirium after cardiac surgery and predictive validity of a risk checklist. Ann Thorac Surg. 2008 Dec;86(6):1883-7. doi: 10.1016/j.athoracsur.2008.08.020.
PubMed 19022003Theologou S, Giakoumidakis K, Charitos C. Perioperative predictors of delirium and incidence factors in adult patients post cardiac surgery. Pragmat Obs Res. 2018 May 8;9:11-19. doi: 10.2147/POR.S157909. eCollection 2018.
PubMed 29773957European Delirium Association; American Delirium Society. The DSM-5 criteria, level of arousal and delirium diagnosis: inclusiveness is safer. BMC Med. 2014 Oct 8;12:141. doi: 10.1186/s12916-014-0141-2.
PubMed 25300023
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Delirium and EuroSCORE II in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05218720
- Acronym / sponsor ID
- 2021-6153-19008
- Conditions
- Delirium
- Keywords
- Cardiac Surgery, Post-operative Delirium, Coronary Artery Bypass Grafting, EuroSCORE II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to find out the association between EuroSCORE II of Delirium in patients undergoing cardiac surgery.
The main questions it aims to answer are the incidence of Delirium in patients undergoing cardiac surgery and to find the association of EuroSCORE II with delirium in cardiac surgery patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients (18-80 years) undergoing elective cardiac surgeries (CABG, MVR, AVR), receiving invasive ventilation
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- ASA I -IV
- Patients undergoing elective cardiac surgery
Key exclusion criteria (6 listed)
- Patients undergoing emergency cardiac surgeries
- History of stroke in the last 6 weeks
- History of delirium
- History of psychiatric illness
- history of medication for psychiatric illness
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 |
|---|---|---|
| EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)* EuroSCORE II is used to predict the risk of in-hospital mortality after cardiac surgery. Where very low risk is <1, low risk is 1-2.99, moderate risk is 3-4.99, and high risk is >5. * CAM- ICU: The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium in patients in intensive care. The score ranges from 0-. Where 0-2 is no delirium, ≥ 3 is positive for delirium, 3-5 mild delirium, 6-7 severe delirium with 7 considered most severe delirium. | Other | – |
Primary outcome
Number of Participants With Delirium
Time frame: Day 1
As per DSM 5 criteria delirium is an acute condition. Symptoms begin over a few hours or a few days. Delirium will be assessed by CAM-ICU score.
Association of Euroscore II Category With Delirium
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24102052Norkiene I, Ringaitiene D, Kuzminskaite V, Sipylaite J. Incidence and risk factors of early delirium after cardiac surgery. Biomed Res Int. 2013;2013:323491. doi: 10.1155/2013/323491. Epub 2013 Sep 12.
- Background: PubMed 17487768Norkiene I, Ringaitiene D, Misiuriene I, Samalavicius R, Bubulis R, Baublys A, Uzdavinys G. Incidence and precipitating factors of delirium after coronary artery bypass grafting. Scand Cardiovasc J. 2007 Jun;41(3):180-5. doi: 10.1080/14017430701302490.
- Background: PubMed 19022003Koster S, Oosterveld FG, Hensens AG, Wijma A, van der Palen J. Delirium after cardiac surgery and predictive validity of a risk checklist. Ann Thorac Surg. 2008 Dec;86(6):1883-7. doi: 10.1016/j.athoracsur.2008.08.020.
- Background: PubMed 29773957Theologou S, Giakoumidakis K, Charitos C. Perioperative predictors of delirium and incidence factors in adult patients post cardiac surgery. Pragmat Obs Res. 2018 May 8;9:11-19. doi: 10.2147/POR.S157909. eCollection 2018.
- Background: PubMed 25300023European Delirium Association; American Delirium Society. The DSM-5 criteria, level of arousal and delirium diagnosis: inclusiveness is safer. BMC Med. 2014 Oct 8;12:141. doi: 10.1186/s12916-014-0141-2.
- Individual participant dataSharing planned: Undecided
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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 Delirium, run by Aga Khan University at 1 site in Pakistan.
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 3 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: finished, as of the sponsor's last update on 8 May 2026. 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 Pakistan. 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 8 May 2026). 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 Delirium (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT05218720, which also lists 5 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 8 May 2026.