Effects of Nutritional Support on Postoperative Delirium

NCT06467552 | Recruiting DMC

• 1 other identifier: 4-2024-0324
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 : 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment 2. Inattention Counting from 20-1 is a simple (if blunt) test for this 3. Disorganized thinking 4. Altered levels of consciousness

  from postoperative day 0 to postoperative day 7

Secondary Outcomes (9)

• duration of delirium

  from postoperative day 0 to postoperative day 7

• type of delirium

  from postoperative day 0 to postoperative day 7

• K-FRAIL for frailty

  from postoperative day 0 to postoperative day 7

• GDS for depression

  from postoperative day 0 to postoperative day 7

• ADL for independence

  from postoperative day 0 to postoperative day 7

Study Arms (2)

control group

ACTIVE COMPARATOR

The entire process is carried out according to Severance Hospital surgical protocols.

Procedure: control group

intervention group

EXPERIMENTAL

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

Interventions

control group PROCEDURE

The entire process is carried out according to Severance Hospital surgical protocols.

control group

Nucare Curact group DIETARY_SUPPLEMENT

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.

intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health system, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Bon-Nyeo koo, MD

CONTACT

82-10-9982-4469; koobn@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 21, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): May 12, 2028
• Last Updated: June 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)