Effects of Nutritional Support on Postoperative Delirium
NCT Number: NCT06467552
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Delirium
Interventions: PROCEDURE: control group|DIETARY_SUPPLEMENT: Nucare Curact group
Sponsor: Yonsei University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 314
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06
Completion Date: 2028-05-12
Locations: Yonsei University Health system, Severance Hospital, Seoul, 03722, Korea, Republic of

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.

Primary Outcome Measures: 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 Outcome Measures: duration of delirium, The Quality of Recovery-40 (QoR-40) : 40\~200(better recovery), from postoperative day 0 to postoperative day 7|type of delirium, 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