Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients

Sepsis Clinical Trial

Official title:

Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911711
• Other study ID #: 2022-03-015-004
• Status: Recruiting
• Start date: July 7, 2023
• Est. completion date: June 7, 2024

Study information

• Verified date: June 2023
• Source: Kangdong Sacred Heart Hospital
• Contact: So Young Park, doctor
• Phone: +8201052058637
• Email: sy.park12[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 7, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Prognostic factor
normal person (no sepsis group)

Locations

Country	Name	City	State
Korea, Republic of	KangdonSHH	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Kangdong Sacred Heart Hospital	Chungnam National University, Chungnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	up to 1 day ICU mortality"	up to 1 day ICU mortality"	up to 1 day ICU mortality"
Secondary	28 days mortality	28 days mortality	28 days mortality