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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06195592
Other study ID # 2023-16/16
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT05063370 - Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac Surgery Phase 2