SepsisNCT05911711
Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients
An observational study of Sepsis, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Prognostic factor
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2023to 7 Jun 2024
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: sepsis patient in Medical ICU sepsis definition : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection
Who may be able to join
- adults over the age of 19 a sepsis patient in ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KangdonSHH
Seoul, 05355
So Young Park, Dr, 8201052058637, sy.park12@gmail.com
About this study
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.
Read the 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
- Conditions
- Sepsis
- Being tested
- Prognostic factor
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic factorOther
normal person (no sepsis group)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prognostic factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
up to 1 day ICU mortality"
up to 1 day ICU mortality"
Measured: up to 1 day ICU mortality"
Secondary outcomes (1)
28 days mortality
28 days mortality
Measured: 28 days mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start7 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Kangdong Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chungnam National University, Chungnam National University Hospital
- Responsible party
- Principal investigator, So Young Park, Kangdong Sacred Heart Hospital
- Investigators
- So Young Park, doctor, Study chair, Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911711
- Sponsor's protocol ID
- 2022-03-015-004
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 28358992Roh 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.
PubMed 39904983
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Clinical Efficacy Analysis of Biomarkers in Sepsis Patients
- ClinicalTrials.gov ID
- NCT05911711
- Acronym / sponsor ID
- 2022-03-015-004
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kangdong Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Chungnam National University, Chungnam National University Hospital
- Study start
- 7 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis patient in Medical ICU | – | Other: Prognostic factorEligibility 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sepsis patient in Medical ICU sepsis definition : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection
Key inclusion criteria (1 listed)
- adults over the age of 19 a sepsis patient in ICU
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic factornormal person (no sepsis group) | Other | Sepsis patient in Medical ICU |
Primary outcome
up to 1 day ICU mortality"
Time frame: up to 1 day ICU mortality"
up to 1 day ICU mortality"
1 secondary outcome
28 days mortality
Time frame: 28 days mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 28358992Park 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.
- Derived from this study: PubMed 39904983Roh 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So Young Park, doctor study chair
Kangdong Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So Young Park, doctor (+8201052058637 ext. KangdongSHH, sy.park12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
up to 1 day ICU mortality" (time frame: up to 1 day ICU mortality"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.