Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Prognostic factor

Detailed Description

Sepsis is a life-threatening condition resulting from a dysregulated host response to infection and remains a significant global health crisis. Accurately identifying high-risk patients and understanding the underlying mechanisms of distinct host responses are crucial. Dysregulation of immune and biological responses, along with metabolic remodeling, has emerged as a prevalent characteristic in sepsis patients. However, there is still a need for a comprehensive understanding of specific markers related to immunometabolism and the underlying mechanisms contributing to the disturbance in sepsis pathogenesis.

This study aims to investigate the immune, biological, and metabolic profiles of sepsis patients, focusing on the alteration of metabolism in sepsis patients with poor outcomes. The findings of this study will provide valuable insights into dysregulated immunometabolism, shedding light on its contribution to the potentiation of immunopathogenesis in sepsis.

Eligibility Criteria adults over the age of 19 a sepsis patient in 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 a patient under the age of 18

Outcome Measure ICU mortality, 28 days mortality Use of inotropics, vasopressors CRRT(continuous renal replacement therapy), ECMO (Extracorporeal membrane oxygenation), Interventional lung assist, polymyxin

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: So Young Park, doctor; Phone Number: KangdongSHH +8201052058637; Email: sy.park12@gmail.com
• Study Contact Backup: Name: Eun-Kyeong Jo, doctor; Phone Number: +8201047628243; Email: hayoungj@cnu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05355
    • Recruiting
    • KangdonSHH
    • Contact: So Young Park, Dr; Phone Number: 8201052058637; Email: sy.park12@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

sepsis patient in Medical ICU sepsis definition : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection

Description

Inclusion Criteria:

• adults over the age of 19 a sepsis patient in ICU

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Prognostic factor; normal person (no sepsis group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
up to 1 day ICU mortality"	up to 1 day ICU mortality"	up to 1 day ICU mortality"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 days mortality	28 days mortality	28 days mortality

Collaborators and Investigators

• Sponsor: Kangdong Sacred Heart Hospital
• Collaborators: Chungnam National University Hospital; Chungnam National University
• Investigators: Study Chair: So Young Park, doctor, Kangdong Sacred Heart Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 7, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 7, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2022-03-015-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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
• IPD Sharing Access Criteria: adults over the age of 19 a sepsis patient in Medical ICU
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No