UMIN-ICDS Clinical Trial

Public title

Association of Perioperative Serum Uric Acid Dynamics with Postoperative Delirium and Postoperative Cognitive Dysfunction: A Prospective Cohort Study in Intensive Care Unit Patients

Acronym

Association of Perioperative Serum Uric Acid Dynamics with Postoperative Delirium and Postoperative Cognitive Dysfunction: A Prospective Cohort Study in Intensive Care Unit Patients

Scientific Title

Association of Perioperative Serum Uric Acid Dynamics with Postoperative Delirium and Postoperative Cognitive Dysfunction: A Prospective Cohort Study in Intensive Care Unit Patients

Scientific Title:Acronym

Association of Perioperative Serum Uric Acid Dynamics with Postoperative Delirium and Postoperative Cognitive Dysfunction: A Prospective Cohort Study in Intensive Care Unit Patients

Region

Japan

Condition

Postoperative delirium; postoperative cognitive dysfunction

Classification by specialty

Anesthesiology	Intensive care medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to investigate the association of perioperative serum uric acid levels and their changes with postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in older patients undergoing major surgery. Exploratory analyses will also examine the associations of gut-related factors with serum uric acid levels, POD, and POCD.

Basic objectives2

Others

Basic objectives -Others

Investigation of the association of perioperative serum uric acid levels and their changes with postoperative delirium and postoperative cognitive dysfunction

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Occurrence of postoperative delirium (POD) during the postoperative observation period. Patients will be assessed twice daily from postoperative day 0 through postoperative day 3 using the CAM-ICU during ICU stay and the CAM after ICU discharge. Patients screening positive for delirium will be evaluated by a psychiatrist according to DSM-5 criteria, and POD will be defined as delirium meeting DSM-5 criteria.

Key secondary outcomes

1) Severity and longitudinal changes in delirium among patients who develop POD, assessed using the MDAS and DRS-R-98.
2) Changes in cognitive function from the preoperative baseline to postoperative day 30 and postoperative day 90, assessed using the MoCA and Trail Making Test Parts A and B.
3) Occurrence of postoperative cognitive dysfunction (POCD) at postoperative day 30 and postoperative day 90.
4) Exploratory associations of gut-related factors with serum uric acid levels, POD, and POCD among participants who consent to stool sample collection.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients aged 65 years or older at the time of informed consent.
2) Patients scheduled for admission to the intensive care unit (ICU) after major surgery.
3) Patients considered able to undergo the assessments required for the primary and secondary outcomes according to the study protocol.
4) Patients who provide written informed consent to participate in the study.

Key exclusion criteria

1) Patients from whom informed consent for study participation cannot be obtained.
2) Patients scheduled to undergo intracranial surgery.
3) Patients with severe neurological disease, psychiatric disease, or dementia, or those considered unable to undergo assessment for postoperative delirium (POD) or postoperative cognitive dysfunction (POCD) because of aphasia, severe hearing impairment, severe visual impairment, prolonged disturbance of consciousness, or similar conditions.
4) Patients with alcohol dependence or a high risk of alcohol withdrawal.
5) Patients considered unsuitable for participation by the principal investigator or study investigators.

Target sample size

350

Name of lead principal investigator

1st name	Naoya
Middle name
Last name	Uemura

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Anesthesiology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

TEL

0878912223

Email

uemura.naoya@kagawa-u.ac.jp

Name of contact person

1st name	Naoya
Middle name
Last name	Uemura

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Anesthesiology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

TEL

0878912223

Homepage URL

Email

uemura.naoya@kagawa-u.ac.jp

Institute

Kagawa University

Institute

Department

Personal name

Naoya Uemura

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee, Faculty of Medicine, Kagawa University

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

Tel

087-898-5111

Email

chiken-m@kagawa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

香川大学医学部附属病院（香川県）

Date of disclosure of the study information

2026

Year

09

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

05

Month

20

Day

Date of IRB

2026

Year

07

Month

31

Day

Anticipated trial start date

2026

Year

09

Month

30

Day

Last follow-up date

2029

Year

06

Month

29

Day

Date of closure to data entry

2029

Year

08

Month

31

Day

Date trial data considered complete

2029

Year

10

Month

31

Day

Date analysis concluded

2030

Year

03

Month

31

Day

Other related information

This study is a single-center, prospective observational cohort study conducted at Kagawa University Hospital. Patients aged 65 years or older who are scheduled for admission to the intensive care unit (ICU) following high-invasive surgery and who meet the eligibility criteria and have provided written informed consent to participate in the study will be prospectively and consecutively enrolled. The primary focus of this study is perioperative serum uric acid levels and their changes; we will evaluate preoperative and postoperative serum uric acid levels, the magnitude of change in uric acid levels, and the uric acid-to-creatinine ratio, among other parameters. The primary outcome measure is the onset of postoperative delirium (POD), and we will secondarily evaluate changes in postoperative cognitive function and postoperative cognitive dysfunction (POCD). We will investigate the association between perioperative serum uric acid dynamics and POD and POCD. Additionally, for study participants who consent to provide stool samples, we will conduct an exploratory analysis of the association between gut microbiota markers and serum uric acid levels, POD, and POCD. This study does not involve any treatment of exposure assignment.

Registered date

2026

Year

09

Month

29

Day

Last modified on

2026

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072209