Effects of Nutritional Support on Postoperative Delirium

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Procedure: control group; Dietary supplement: Nucare Curact group

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bon-Nyeo koo, MD; Phone Number: 82-10-9982-4469; Email: koobn@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: bon nyeo koo, MD; Phone Number: 82-10-9982-4469; Email: koobn@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; The entire process is carried out according to Severance Hospital surgical protocols.	Procedure: control group; The entire process is carried out according to Severance Hospital surgical protocols.
Experimental: intervention 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of delirium		from postoperative day 0 to postoperative day 7
duration of delirium	The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)	from postoperative day 0 to postoperative day 7
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
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
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
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
QOR-40 for recovery	The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)	from postoperative day 0 to postoperative day 7
K-MoCA for cognitive dysfunction	Korean-Montreal Cognitive Assessment(K-MoCA) : 0~30, cognitive dysfunction<23.	from postoperative day 0 to postoperative day 7
IADL for independence	Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0~8(complete independence).	from postoperative day 0 to postoperative day 7

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): May 12, 2028

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: 4-2024-0324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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