Delirium and EuroSCORE II in Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Other: EuroSCORE II risk score and CAM-ICU (The Confusion Assessment Method for the Intensive Care Unit)

Detailed Description

Patients undergoing cardiac surgery are at risk of developing delirium which is a frequent psychiatric condition found in ICU participants especially cardiac surgery patients. It presents with decreased levels of consciousness followed by a cognitive decline which is sometimes difficult to recognize along with altered sleep patterns. Hospital stay is increased for these patients, along with increased ICU stay which impacts morbidity and mortality and increases costs. The condition negatively impacts the post-op rehabilitation, quality of life and leads to social dependence for the patient, especially those who are older are at higher risks for long term cognitive dysfunction.

The diagnosis and monitoring of delirium remains a challenge because of the fluctuating course and different manifestations of the condition. There are wide variations in the incidence rates that are reported and are dependent on the diagnostic methods. The incidence of postoperative delirium in cardiac patients has been reported to be around 10-60 % and cognitive dysfunction occurs in up to 79% of these patients. Older patients have a high risk of developing deliriums in up to 73% of patients and in the ICU setting this rate is even higher up to 81%. Recognition of the disease can be helped with delirium rating scales and checklists but mostly is a clinical diagnosis. It is important to recognize the large number of risk factors that can be associated with the condition but more importantly the type of surgery can also impact the development of post-operative dementia. In CABG(Coronary Artery Bypass Grafting) the overall incidence of POD (Post Operative Delirium) was 7.9% while it was 11.2% after valvular surgery according to one study.

Patients undergoing cardiac surgery mostly require risk stratification and prediction models which are important tools for making medical decisions. One of the most used prediction models is the EuroSCORE II risk model, which includes 17 independent variables and considers 30 days' operative mortality. It is used for assessing the risk associated with heart surgery and is based on the European cardiac surgical database. Various studies have reported an association between higher scores on the EuroSCORE II system and the association with developing delirium.

With this, the investigators will study the association between EuroSCORE II and delirium in cardiac surgery patients and see if an increased preoperative EuroSCORE II leads to the development of delirium. It will help refute claims of the advantage of EuroSCORE II in predicting delirium after cardiac surgery. No such study has been performed in our country previously.

The rationale of this study is to see whether both the development of delirium and EuroSCORE II are independent of each other or if there is an association between the two.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Coronary Artery Bypass Grafting; Post-operative Delirium; EuroSCORE II
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Delirium
• Other Study ID Numbers: 2021-6153-19008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No