Postoperative DeliriumNCT06467552
Effects of Nutritional Support on Postoperative Delirium
A study testing Nucare Curact group in people with Postoperative Delirium, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Nucare Curact group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2024to 12 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health system, Severance Hospital
Seoul, 03722
bon nyeo koo, MD, 82-10-9982-4469, koobn@yuhs.ac
About this study
Official title: 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.
- Conditions
- Postoperative Delirium
- Being tested
- control group, Nucare Curact group
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupProcedure or surgery
The entire process is carried out according to Severance Hospital surgical protocols.
Nucare Curact groupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The entire process is carried out according to Severance Hospital surgical protocols. Receives: 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. Receives: Dietary Supplement: Nucare Curact group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from postoperative day 0 to postoperative day 7
Secondary outcomes (9)
duration of delirium
The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)
Measured: from postoperative day 0 to postoperative day 7
type of delirium
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from postoperative day 0 to postoperative day 7
QOR-40 for recovery
The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)
Measured: from postoperative day 0 to postoperative day 7
K-MoCA for cognitive dysfunction
Korean-Montreal Cognitive Assessment(K-MoCA) : 0~30, cognitive dysfunction<23.
Measured: from postoperative day 0 to postoperative day 7
IADL for independence
Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0~8(complete independence).
Measured: from postoperative day 0 to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study startJun 2024 (estimated)
- Primary completion12 May 2028 (estimated)
- Study completion12 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467552
- Sponsor's protocol ID
- 4-2024-0324
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison
- ClinicalTrials.gov ID
- NCT06467552
- Acronym / sponsor ID
- 4-2024-0324
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- 12 May 2028 (estimated)
- Study completion
- 12 May 2028 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: control groupThe entire process is carried out according to Severance Hospital surgical protocols. |
| intervention group | Experimental | Dietary Supplement: Nucare Curact groupThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control groupThe entire process is carried out according to Severance Hospital surgical protocols. | Procedure or surgery | control group |
| Nucare Curact groupThe 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 | intervention group |
Primary outcome
incidence of postoperative delirium
Time frame: from postoperative day 0 to postoperative day 7
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
9 secondary outcomes
duration of delirium
Time frame: from postoperative day 0 to postoperative day 7
type of delirium
Time frame: from postoperative day 0 to postoperative day 7
K-FRAIL for frailty
Time frame: from postoperative day 0 to postoperative day 7
GDS for depression
Time frame: from postoperative day 0 to postoperative day 7
ADL for independence
Time frame: from postoperative day 0 to postoperative day 7
SNSB-c for cognitive dysfunction
Time frame: from postoperative day 0 to postoperative day 7
QOR-40 for recovery
Time frame: from postoperative day 0 to postoperative day 7
K-MoCA for cognitive dysfunction
Time frame: from postoperative day 0 to postoperative day 7
IADL for independence
Time frame: from postoperative day 0 to postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucare Curact group in people with Postoperative Delirium, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bon-Nyeo koo, MD (82-10-9982-4469, koobn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative delirium (time frame: from postoperative day 0 to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.