Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients
1 other identifier
observational
120
1 country
1
Brief Summary
Sepsis, a severe response to bacterial infection, lacks understanding of immunometabolic features that can identify high-risk patients. This study aimed to discover immune, biological, and metabolic biomarkers in sepsis patients with poor prognosis and understand the underlying mechanisms of host immune responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
July 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2024
CompletedJune 22, 2023
June 1, 2023
6 months
June 7, 2023
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
up to 1 day ICU mortality"
up to 1 day ICU mortality"
up to 1 day ICU mortality"
Secondary Outcomes (1)
28 days mortality
28 days mortality
Study Arms (1)
Sepsis patient in Medical ICU
Eligibility Criteria: adults over the age of 19 a sepsis patient in Medical ICU Patients are excluded from the study : If the patient or care giver does not agree to participate in the study a bone marrow transplant or an organ transplant patient a Do not resuscitation (DNR) patient
Interventions
Eligibility Criteria
sepsis patient in Medical ICU sepsis definition : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection
You may qualify if:
- adults over the age of 19 a sepsis patient in ICU
You may not qualify if:
- If the patient or care giver does not agree to participate in the study a bone marrow transplant or an organ transplant patient a DNR patient a patient under the age of 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kangdong Sacred Heart Hospitallead
- Chungnam National Universitycollaborator
- Chungnam National University Hospitalcollaborator
Study Sites (1)
KangdonSHH
Seoul, 05355, South Korea
Related Publications (2)
Park SY, Shrestha S, Youn YJ, Kim JK, Kim SY, Kim HJ, Park SH, Ahn WG, Kim S, Lee MG, Jung KS, Park YB, Mo EK, Ko Y, Lee SY, Koh Y, Park MJ, Song DK, Hong CW. Autophagy Primes Neutrophils for Neutrophil Extracellular Trap Formation during Sepsis. Am J Respir Crit Care Med. 2017 Sep 1;196(5):577-589. doi: 10.1164/rccm.201603-0596OC.
PMID: 28358992BACKGROUNDRoh T, Ju S, Park SY, Ahn Y, Chung J, Nakano M, Ryu G, Kim YJ, Kim G, Choi H, Lee SG, Kim IS, Lee SI, Chung C, Shimizu T, Miyoshi E, Jung SS, Park C, Yamasaki S, Park SY, Jo EK. Fucosylated haptoglobin promotes inflammation via Mincle in sepsis: an observational study. Nat Commun. 2025 Feb 4;16(1):1342. doi: 10.1038/s41467-025-56524-3.
PMID: 39904983DERIVED
Biospecimen
Blood for (RNAseq) Bronchoalveolar lavage (for microbiome)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
So Young Park, doctor
Kangdong Sacred Heart Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 28 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
June 7, 2023
First Posted
June 22, 2023
Study Start
July 7, 2023
Primary Completion
December 31, 2023
Study Completion
June 7, 2024
Last Updated
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Keeping research-related records for three years from the time the research is completed pursuant to Article 15 of the Enforcement Rule of the Bioethics and Safety Act
- Access Criteria
- adults over the age of 19 a sepsis patient in Medical ICU
This study complies with the Helsinki Declaration, is conducted in accordance with the test plan approved by the Institutional Bioethics Committee (IRB) of Kangdong Sacred Heart Hospital, and will be conducted in accordance with the clinical trial management standards (GCP) set by the Korea Food and Drug Administration. Personal information is not included in the research results, and for this purpose, personal information will not be included even when the research results are published and the research results are disclosed by assigning a code number to the research results. Clinical Information Analysis reviews patient's charts and the lead researcher is responsible for the supervision of the state to ensure that personal information collected before being coded is not leaked.