Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062568) titled 'A study investigating the relationship between preoperative salivary components and postoperative infection and organ dysfunction' on Aug. 13.

Study Type: Observational

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Postoperative infection, postoperative sepsis, and postoperative organ dysfunction in adult surgical patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to determine the association between preoperative salivary metabolomic profiles and postoperative sepsis defined according to Sepsis-3 criteria within 30 days after surgery by linking existing preoperative salivary metabolomic data with postoperative clinical data at Yamagata University Hospital.

The secondary objectives are to investigate the associations between preoperative salivary metabolomic profiles and postoperative infection, septic shock, postoperative SOFA score, organ-specific dysfunction, inflammatory responses, organ support therapies, ICU/HCU admission, length of hospital stay, and mortality. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants must meet all of the following criteria:

Preoperative salivary metabolomic analysis was performed at Yamagata University between April 11, 2016 and May 22, 2025, and the resulting data are available in the existing database Salivary metabolomic data can be linked to clinical data from Yamagata University Hospital The participant underwent surgery at Yamagata University Hospital after saliva collection The participant was 18 years of age or older at the time of surgery Clinical information required to evaluate infection and organ dysfunction within 30 days after surgery or during the index hospitalization is available Key exclusion criteria - Participants meeting any of the following criteria will be excluded:

The planned surgery was not performed after saliva collection Information required to determine the primary outcome, including infection-related data or SOFA score components, is substantially incomplete Salivary metabolomic data cannot be appropriately linked to clinical data The participant has opted out of the use of their data for this study The principal investigator considers the participant unsuitable for inclusion for another reason Target Size - 4000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 10 Day Date of IRB - 2026 Year 08 Month 10 Day Anticipated trial start date - 2026 Year 08 Month 14 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071619

Disclaimer: Curated by HT Syndication.