Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061862) titled 'An Exploratory Prospective Observational Study on the Involvement of Neutrophil-Derived Factors in the Pathogenesis of Sepsis' on June 12.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Medical University
Condition:
Condition - Sepsis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This exploratory study aims to investigate how structural changes in neutrophils and neutrophil-derived factors contribute to the pathogenesis of sepsis.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Adults aged 18 years or older.
2) Patients who are clinically suspected of having an infectious disease and are classified as an intermediate-risk group according to the National Early Warning Score 2 (NEWS2), defined as a total NEWS2 score of 5 points or higher or a score of 3 points in any single parameter.
3) Healthy controls are defined as individuals with no history of chronic diseases or malignancies, who are not currently receiving medical treatment on an outpatient basis, who do not smoke, and whose alcohol consumption is less than one serving of sake (approximately 180 mL) per day. Healthy volunteers will be recruited through posters displayed in Building 3 of the Faculty of Science, The University of Tokyo.
4) Patients or healthy controls from whom written informed consent for study participation has been obtained from the individual themselves or, when applicable, from their legally authorized representative.
Key exclusion criteria - 1) Patients presenting with trauma.
2)Individuals deemed inappropriate for inclusion in the study by the investigator for any other reason.
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 24 Day
Date of IRB - 2026 Year 03 Month 06 Day
Anticipated trial start date - 2026 Year 03 Month 09 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069237
Disclaimer: Curated by HT Syndication.