Effects of Nutritional Support on Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467552
• Other study ID #: 4-2024-0324
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 12, 2028

Study information

• Verified date: May 2024
• Source: Yonsei University
• Contact: Bon-Nyeo koo, MD
• Phone: 82-10-9982-4469
• Email: koobn[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, single-center, randomized controlled trial to compare whether applying nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: May 12, 2028
• Est. primary completion date: May 12, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Elderly patients aged 65 and above.

• Patients undergoing non-cardiac major surgery in thoracic surgery, lung cancer surgery, multi-level spinal surgery in neurosurgery and orthopedics, or liver cancer surgery in hepatobiliary and pancreatic surgery, under general anesthesia with an expected surgery duration of 2 hours or more.

• Patients scheduled for arterial catheterization.

• Patients who are able to take oral intake from postoperative day #1.

Exclusion Criteria:

• Patients with uncontrolled systemic conditions such as diabetes, hypertension, renal disease, liver disease, and other systemic illnesses.

• Those with visual impairment.

• Patients with cognitive impairment based on the Mini-Mental State Examination for Dementia Screening criteria.

• Individuals experiencing difficulty in communication.

• Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).

• Patients diagnosed with alcohol or substance addiction.

• Patients with cancelled scheduled surgeries.

• Patients undergoing minor surgeries with expected anesthesia durations of less than 2 hours.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Procedure:
• control group
The entire process is carried out according to Severance Hospital surgical protocols.

Dietary Supplement:
• Nucare Curact group
The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery. In addition, the patients of control group will be instructed to take up to 4 doses of the nutritional supplement (Nucare Curact provided by DAESANG Wellife Inc.) per day for approximately 2 weeks before surgery and for about 4 weeks after surgery.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health system, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative delirium	Confusion assessment methods(CAM) will be used for diagnosing delirium At least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes; and emotional disturbances).; ** Confusion assessment methods(CAM) diagnostic algorism (positive or negative result, positive means delirium); CAM is considered positive if features 1 and 2 are present, with at least one of features 3 or 4. Below are the four criteria of features : Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment; Inattention Counting from 20-1 is a simple (if blunt) test for this; Disorganized thinking; Altered levels of consciousness	from postoperative day 0 to postoperative day 7
Secondary	duration of delirium	The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)	from postoperative day 0 to postoperative day 7
Secondary	type of delirium		from postoperative day 0 to postoperative day 7
Secondary	K-FRAIL for frailty	The Korean version of the fatigue, resistance, ambulation, illnesses, and loss of weight (K-FRAIL) scale : 0(healthy)~8(frail).; A raw score is standardized. A lower score means cognitive dysfunction.	from postoperative day 0 to postoperative day 7
Secondary	GDS for depression	Geriatric Depression Scale(GDS) : 0(normal)~ 15(depression). A raw score is standardized. A lower score means cognitive dysfunction.	from postoperative day 0 to postoperative day 7
Secondary	ADL for independence	Activities of Daily Living(ADL)-Barthel Index : 0(completely dependent )~105( independent).; A raw score is standardized. A lower score means cognitive dysfunction.	from postoperative day 0 to postoperative day 7
Secondary	SNSB-c for cognitive dysfunction	Seoul Neuropsychological Screening Battery-Core(SNSB-C): total score is 617. A raw score is standardized. A lower score means cognitive dysfunction.	from postoperative day 0 to postoperative day 7
Secondary	QOR-40 for recovery	The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)	from postoperative day 0 to postoperative day 7
Secondary	K-MoCA for cognitive dysfunction	Korean-Montreal Cognitive Assessment(K-MoCA) : 0~30, cognitive dysfunction<23.	from postoperative day 0 to postoperative day 7
Secondary	IADL for independence	Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0~8(complete independence).	from postoperative day 0 to postoperative day 7