Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063104) titled 'Association of Perioperative Serum Uric Acid Dynamics with Postoperative Delirium and Postoperative Cognitive Dysfunction: A Prospective Cohort Study in Intensive Care Unit Patients' on Sept. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Kagawa University
Condition:
Condition - Postoperative delirium; postoperative cognitive dysfunction
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
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 Size - 350
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072209
Disclaimer: Curated by HT Syndication.