Development of Delirium in Patients Undergoing Open-Heart Surgery

Open-Heart Surgery Clinical Trial

Official title:

The Effect of Nutritional Status of Patients Undergoing Open-Heart Surgery on The Development Postoperative Delirium

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06195592
• Other study ID #: 2023-16/16
• Status: Active, not recruiting
• Start date: September 15, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Malnutrition is a prevalent issue among patients undergoing cardiac surgery. This can lead to delirium risk factors, including postoperative functional and cognitive impairment. Assessing the patient's nutritional status before open-heart surgery may decrease the incidence of delirium and the psychological and physiological problems associated with it. The objective of this study was to examine the relationship between nutritional status and the incidence of postoperative delirium in patients who have undergone open-heart surgery.

Description:

Upon examining the literature, it was found that the incidence of delirium after open heart surgery ranged from 3% to 70% (Tomakin et al., 2020). Postoperative delirium has numerous risk factors, including predisposing and accelerating factors. Predisposing risk factors comprise malnutrition and electrolyte imbalance, cognitive impairment, depression, and other psychiatric disorders such as dementia (Velayati et al., 2019; Wilson et al., 2020). This study aims to investigate the relationship between the nutritional status of patients undergoing open heart surgery and the development of postoperative delirium. The study will be conducted in the Cardiovascular Surgery Intensive Care Unit of Bursa Uludag University Health Application and Research Centre Hospital between September 2023 and February 2024. Data will be collected using the Personal Information Form, Nutritional Risk Screening Score 2002 (NRS-2002), Delirium Risk Assessment Form, Visual Analogue Scale for Pain Levels, Richmond Agitation Sedation Scale, Glasgow Coma Scale, and Confusion Assessment Scale in Intensive Care Unit.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Over 18 years old
• Having undergone open heart surgery
• No mental deficiency and visual and hearing impairment
• No psychiatric diagnosis and no medication for this purpose
• 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)

Exclusion Criteria:

• Open heart surgery under emergency conditions
• Diagnosed with delirium, dementia, psychiatric illness before surgery
• Alcohol and drug addiction
• Dying in the intensive care unit within 24 hours

Related Conditions & MeSH terms

• Delirium
• Open-Heart Surgery

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Kubra Gunes

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Velayati A, Vahdat Shariatpanahi M, Shahbazi E, Vahdat Shariatpanahi Z. Association between preoperative nutritional status and postoperative delirium in individuals with coronary artery bypass graft surgery: A prospective cohort study. Nutrition. 2019 Oc — View Citation

Wilson JE, Mart MF, Cunningham C, Shehabi Y, Girard TD, MacLullich AMJ, Slooter AJC, Ely EW. Delirium. Nat Rev Dis Primers. 2020 Nov 12;6(1):90. doi: 10.1038/s41572-020-00223-4. Erratum In: Nat Rev Dis Primers. 2020 Dec 1;6(1):94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recognising Delirium	Recognising delirium in malnourished patients prior to open heart surgery	6 months