NCT06195592

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Keywords

deliriummalnutritionopen-heart surgery

Outcome Measures

Primary Outcomes (1)

  • Recognising Delirium

    Recognising delirium in malnourished patients prior to open heart surgery

    6 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

To be eligible for the study, the patient must be at least 18 years old and have undergone open-heart surgery. They should not have any mental or sensory impairments, psychiatric diagnoses, or be taking medication for this purpose. Additionally, they should not be in a coma, with a RASS score between -3 and +4 and a GCS score of 10 or higher.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

Related 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.

  • 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.

  • 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 Oct;66:227-232. doi: 10.1016/j.nut.2019.06.006. Epub 2019 Jun 14.

MeSH Terms

Conditions

DeliriumMalnutrition

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nursel Vatansever

    Uludag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RN, MSc

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

September 15, 2023

Primary Completion

October 31, 2024

Study Completion

November 30, 2024

Last Updated

January 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations