Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients

Sponsor

Kangdong Sacred Heart Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05911711

Collaborator

Chungnam National University (Other), Chungnam National University Hospital (Other)

120

Enrollment

Location

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients

Anticipated Study Start Date :

Jul 7, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 7, 2024

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

up to 1 day ICU mortality" [up to 1 day ICU mortality"]
up to 1 day ICU mortality"

Secondary Outcome Measures

28 days mortality [28 days mortality]
28 days mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KangdonSHH	Seoul		Korea, Republic of	05355

Sponsors and Collaborators

Kangdong Sacred Heart Hospital
Chungnam National University
Chungnam National University Hospital

Investigators

Study Chair: So Young Park, doctor, Kangdong Sacred Heart Hospital

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

So Young Park, associate professor, Kangdong Sacred Heart Hospital

ClinicalTrials.gov Identifier:

NCT05911711

Other Study ID Numbers:

2022-03-015-004

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Toxemia

Study Results

No Results Posted as of Jun 22, 2023