NCT05218720

Brief 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 surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

January 31, 2022

Results QC Date

December 20, 2023

Last Update Submit

May 7, 2026

Conditions

Keywords

Cardiac SurgeryPost-operative DeliriumCoronary Artery Bypass GraftingEuroSCORE II

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 1

  • Association of Euroscore II Category With Delirium

    Day 1

Interventions

* 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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (18-80 years) undergoing elective cardiac surgeries (CABG, MVR, AVR), receiving invasive ventilation

You may qualify if:

  • Age greater than or equal to 18 years
  • ASA I -IV
  • Patients undergoing elective cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 24102052BACKGROUND
  • Norkiene 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.

    PMID: 17487768BACKGROUND
  • Koster 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.

    PMID: 19022003BACKGROUND
  • Theologou 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.

    PMID: 29773957BACKGROUND
  • European 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.

    PMID: 25300023BACKGROUND

MeSH Terms

Conditions

DeliriumEmergence Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic Processes

Results Point of Contact

Title
Dr Khalid Siddiqui
Organization
Aga Khan University Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 1, 2022

Study Start

March 1, 2022

Primary Completion

May 23, 2023

Study Completion

May 24, 2024

Last Updated

May 8, 2026

Results First Posted

May 8, 2026

Record last verified: 2026-05

Locations