Perioperative IL-33 is Associated with the Early Stage of Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery

NCT06704451 | Recruiting DMC

• 1 other identifier: 1stKunmingMC1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative neurocognitive dysfunction(PND) are common complications of major surgery among patients, could be a long-term disease, which sometimes lasts for several years, and it is meaningful to find a biomarker of PND at the early stage.As far as we know, the relationship between IL-33 and PND is not clear yet in the gastrointestinal and hepatic area. Thus, the investigators designed this study to find out the association between IL-33 and occurrence of PND, and determine whether IL-33 could be a biomarker of the early stage of PND.Study population included 150 subjects. Neuropsychological questionnaire were administrated one day before surgery and three days after surgery. And the end of the operation peripheral venous blood was sampled to measure IL-33 inflammatory protein expression in peripheral blood monocytes. Analyze the data and draw conclusions.

Conditions

Postoperative Neurocognitive Dysfunction; Cognitive Dysfunction; Postoperative Complications; Neuropsychological Tests

Keywords

Interleukin-33; Postoperative Neurocognitive Dysfunction; Postoperative Complications; Inflammasomes

Outcome Measures

Primary Outcomes (1)

• The association between peripheral blood IL-33 inflammasome level and postoperative cognitive dysfunction

  Postoperative cognitive dysfunction (POCD) was defined by Z scores. The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 2 or more. Neuropsychological tests included MMSE,Hopkins Verbal Learning Test-Revised, Brief Visuospatial Memory Test-Revised,Trail Making Test, Digital Scope Test,Word Delayed Recall Test, Word Delayed Interference Test, Image Delayed Recall Test. Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject standard deviation to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the standard deviation for this sum of Z scores in the control subjects, creating a combined Z score. The test results were adjusted so that a positive Z score indicated deterioration from the baseline test.

  Expected completion date: June 18, 2025

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Abdominal surgery patients

You may not qualify if:

• history of mental diseases;
• patients with current Neurological disease;
• patients who refused or were unable to finish the neurocognitive evaluation;
• preoperative Mini-Mental Stare Examination (MMSE) less than required score (illiteracy \<17; primary school \< 20; middle school and higher \< 24).

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

The first affiliated hospital of KUNMING medical university

Kunming, Yunnan, 650032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Cognitive Dysfunction; Postoperative Complications

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of The first affiliated hospital of KUNMING medical university

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 26, 2024
• Study Start: August 18, 2014
• Primary Completion: June 18, 2025
• Study Completion: December 30, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-10

Locations

CN (1)