SepsisNCT06920420
Novel Biomarkers Related Xuebijing Injection Improves Sepsis
An observational study of Sepsis, run by Southeast University, China.
Trial summary
Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sepsis
Who may be able to join
- Meeting the Sepsis 3.0 diagnostic criteria;
- SOFA score ≥ 2 and < 13;
- Signed informed consent.
Who cannot join
- Age <18 years or >75 years;
- Pregnant or lactating women;
- Presence of severe primary diseases including malignant tumors severe hematologic disorders and HIV infection;
- Current use of immunosuppressants or history of organ transplantation within the past 6 months;
- Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
About this study
Official title: Xuebijing Injection Regulates Endothelial Cell Panapoptosis in Treating Sepsis Through PCDHAC2/BAX/AIM2 Pathway
Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Xuebijing treatment group | Based on the standard treatment group Xuebijing injection was added. | |
| Standard treatment group | Patients with sepsis are given standard treatment according to international guidelines for the management of sepsis and septic shock | |
| Healthy Volunteer Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.
Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.
Measured: Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Mar 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920420
- Sponsor's protocol ID
- 2024ZDSYLL513-P01
- Other IDs
- 82472202
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data, including genetic information, will not be shared due to privacy and ethical considerations. Genetic data is highly sensitive and could potentially identify individuals. To protect patient confidentiality and comply with regulations such as GDPR and HIPAA, access to such data is strictly limited and will only be shared under explicit informed consent and approved ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xuebijing Injection Regulates Endothelial Cell Panapoptosis in Treating Sepsis Through PCDHAC2/BAX/AIM2 Pathway
- ClinicalTrials.gov ID
- NCT06920420
- Acronym / sponsor ID
- 2024ZDSYLL513-P01
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Apr 2025 (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 is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xuebijing treatment group | – | –Based on the standard treatment group Xuebijing injection was added. |
| Standard treatment group | – | –Patients with sepsis are given standard treatment according to international guidelines for the management of sepsis and septic shock |
| Healthy Volunteer Group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis
Key inclusion criteria (3 listed)
- Meeting the Sepsis 3.0 diagnostic criteria;
- SOFA score ≥ 2 and < 13;
- Signed informed consent.
Key exclusion criteria (5 listed)
- Age <18 years or >75 years;
- Pregnant or lactating women;
- Presence of severe primary diseases including malignant tumors severe hematologic disorders and HIV infection;
- Current use of immunosuppressants or history of organ transplantation within the past 6 months;
- Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.
Time frame: Day7
Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided. Individual patient data, including genetic information, will not be shared due to privacy and ethical considerations. Genetic data is highly sensitive and could potentially identify individuals. To protect patient confidentiality and comply with regulations such as GDPR and HIPAA, access to such data is strictly limited and will only be shared under explicit informed consent and approved ethical guidelines.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Southeast University, China.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles. (time frame: Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.