SepsisRSPNCT06068192
Registration of Sepsis Patients in the Emergency Department
An observational study of Sepsis, run by The First Hospital of Jilin University.
Trial summary
1) Establish a clinical data database for sepsis patients in the Emergency Department of the First Hospital of Jilin University. Describe the clinical data and prognosis of patients with simple systemic inflammatory response syndrome (common infection), pre sepsis, sepsis, and septic shock. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sepsis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Oct 2026
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study site and population included patients with systemic inflammatory response syndrome caused by "infectious factors" who were admitted to the Emergency Department of the First Hospital of Jilin University from January 1, 2023 to December 31, 2027. The screening criteria for the study population were patients with "systemic inflammatory response syndrome" caused by sensory factors who were continuously registered and treated at the Emergency Department of the First Affiliated Hospital of Jilin University from January 1, 2023 to December 31, 2027.
Who may be able to join
- Age greater than or equal to 15 years old; 2) A patient who sought medical treatment at the Emergency Department of Jilin University First Hospital due to "systemic inflammatory response syndrome" (see relevant concepts and definitions in section 4.2 below). 3) Within 24 hours of seeking medical attention, evidence of "infection" can be clearly detected through imaging and laboratory examinations. Patients can be diagnosed and classified as at least one of the following conditions: respiratory system infection, digestive system infection, urinary system infection, blood borne infection, or skin soft tissue infection.
Who cannot join
- pregnant and lactating women; 2) Active pulmonary tuberculosis; 3) Patients who do not agree to participate in this study.
About this study
Official title: A Study on the Registration of Sepsis Patients in the Emergency Department of the First Hospital of Jilin University
- Establish a clinical data database for sepsis patients in the Emergency Department of the First Hospital of Jilin University. Describe the clinical data and prognosis of patients with simple systemic inflammatory response syndrome (common infection), pre sepsis, sepsis, and septic shock. 2) Explore the risk factors related to the progression of sepsis in patients in the early stages, as well as the risk factors related to the patient's prognosis. 3) Analyze the risk factors related to the prognosis of sepsis patients, and provide clinical basis for the treatment and long-term prognosis of sepsis patients. 4) Search for diagnostic biomarkers and prognostic serum biomarkers for patients with sepsis, sepsis, and septic shock.
Read the detailed description
The study site and population included patients with systemic inflammatory response syndrome caused by "infectious factors" who were admitted to the Emergency Department of the First Hospital of Jilin University from January 1, 2023 to December 31, 2027. The screening criteria for the study population were patients with "systemic inflammatory response syndrome" caused by sensory factors who were continuously registered and treated at the Emergency Department of the First Affiliated Hospital of Jilin University from January 1, 2023 to December 31, 2027. A. Inclusion criteria: 1) Age greater than or equal to 15 years old; 2) A patient who sought medical treatment at the Emergency Department of Jilin University First Hospital due to "systemic inflammatory response syndrome" (see relevant concepts and definitions in section 4.2 below). 3) Within 24 hours of seeking medical attention, evidence of "infection" can be clearly detected through imaging and laboratory examinations. Patients can be diagnosed and classified as at least one of the following conditions: respiratory system infection, digestive system infection, urinary system infection, blood borne infection, or skin soft tissue infection. B. Exclusion criteria: Patients with any of the following conditions need to be excluded from this study, including: 1) pregnant and lactating women; 2) Active pulmonary tuberculosis; 3) Patients who do not agree to participate in this study. The follow-up strategy is to follow up for 1 month and 3 months after discharge. Obtain patient information through telephone follow-up or on-site follow-up, with a loss of follow-up rate not exceeding 20%. The telephone follow-up includes the patient's daily discomfort symptoms, whether the infection has recurred, whether infection related symptoms have reappeared, if there is any organ damage upon discharge, it is necessary to inquire about re examination and recovery status, whether there are new diseases and treatment measures, and medication status; The follow-up at the hospital includes the patient's basic vital signs, blood routine, liver function, kidney function, cardiac ultrasound, and quality of life assessment. Please refer to the attachment for details< Table 3. Patient Follow up Information Collection Table>Follow up Time Range Follow up Method: 1 month before discharge, 1 week phone follow-up and/or hospital visit. 2 months after discharge, 1 week phone follow-up and/or hospital visit. Related concepts and definitions: A. Systemic Inflammatory Response Syndrome (SIRS) (refer to the 8th edition of Internal Medicine and the 2nd edition of Emergency Medicine), with the presence of corresponding injury factors, SIRS can be diagnosed if two or more of the following occur. 1) Body temperature>38 ℃ or<36 ℃. 2) Heart rate>90 beats per minute or hypotension (systolic blood pressure<90 mmHg, or a decrease of>40 mmHg from baseline). 3) Shortness of breath (>20 breaths/minute) or hyperventilation (PaCO2<32mmHg). 4) Peripheral blood white blood cell count greater than 12 × 109/L or less than 4 × 109/L, or immature white blood cells greater than 10%, but other reasons that can cause the aforementioned acute abnormal changes should be ruled out. B. Grouping of SIRS patients: The diagnostic criteria in this section refer to the 2021 Surviving sepsis campaign guidelines
- Conditions
- Sepsis
- Being tested
- no intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 28th day death group | Patient dies within 28 days after hospitalization Receives: Other: no intervention | |
| non-28th day death group | The patient does not die within 28 days after hospitalization Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient dies within 28 days after hospitalization
The patient dies within 28 days after hospitalization
Measured: within 28 days after hospitalization
The patient does not die within 28 days after hospitalization
The patient does not die within 28 days after hospitalization
Measured: within 28 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (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.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068192
- Sponsor's protocol ID
- RSP
- Acronym
- RSP
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Registration of Sepsis Patients in the Emergency Department of the First Hospital of Jilin University
- ClinicalTrials.gov ID
- NCT06068192
- Acronym / sponsor ID
- RSP / RSP
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Oct 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.
- Establish a clinical data database for sepsis patients in the Emergency Department of the First Hospital of Jilin University. Describe the clinical data and prognosis of patients with simple systemic inflammatory response syndrome (common infection), pre sepsis, sepsis, and septic shock. 2) Explore the risk factors related to the progression of sepsis in patients in the early stages, as well as the risk factors related to the patient's prognosis. 3) Analyze the risk factors related to the prognosis of sepsis patients, and provide clinical basis for the treatment and long-term prognosis of sepsis patients. 4) Search for diagnostic biomarkers and prognostic serum biomarkers for patients with sepsis, sepsis, and septic shock.
Detailed description
The study site and population included patients with systemic inflammatory response syndrome caused by "infectious factors" who were admitted to the Emergency Department of the First Hospital of Jilin University from January 1, 2023 to December 31, 2027. The screening criteria for the study population were patients with "systemic inflammatory response syndrome" caused by sensory factors who were continuously registered and treated at the Emergency Department of the First Affiliated Hospital of Jilin University from January 1, 2023 to December 31, 2027. A. Inclusion criteria: 1) Age greater than or equal to 15 years old; 2) A patient who sought medical treatment at the Emergency Department of Jilin University First Hospital due to "systemic inflammatory response syndrome" (see relevant concepts and definitions in section 4.2 below). 3) Within 24 hours of seeking medical attention, evidence of "infection" can be clearly detected through imaging and laboratory examinations. Patients can be diagnosed and classified as at least one of the following conditions: respiratory system infection, digestive system infection, urinary system infection, blood borne infection, or skin soft tissue infection. B. Exclusion criteria: Patients with any of the following conditions need to be excluded from this study, including: 1) pregnant and lactating women; 2) Active pulmonary tuberculosis; 3) Patients who do not agree to participate in this study. The follow-up strategy is to follow up for 1 month and 3 months after discharge. Obtain patient information through telephone follow-up or on-site follow-up, with a loss of follow-up rate not exceeding 20%. The telephone follow-up includes the patient's daily discomfort symptoms, whether the infection has recurred, whether infection related symptoms have reappeared, if there is any organ damage upon discharge, it is necessary to inquire about re examination and recovery status, whether there are new diseases and treatment measures, and medication status; The follow-up at the hospital includes the patient's basic vital signs, blood routine, liver function, kidney function, cardiac ultrasound, and quality of life assessment. Please refer to the attachment for details< Table 3. Patient Follow up Information Collection Table>Follow up Time Range Follow up Method: 1 month before discharge, 1 week phone follow-up and/or hospital visit. 2 months after discharge, 1 week phone follow-up and/or hospital visit. Related concepts and definitions: A. Systemic Inflammatory Response Syndrome (SIRS) (refer to the 8th edition of Internal Medicine and the 2nd edition of Emergency Medicine), with the presence of corresponding injury factors, SIRS can be diagnosed if two or more of the following occur. 1) Body temperature>38 ℃ or<36 ℃. 2) Heart rate>90 beats per minute or hypotension (systolic blood pressure<90 mmHg, or a decrease of>40 mmHg from baseline). 3) Shortness of breath (>20 breaths/minute) or hyperventilation (PaCO2<32mmHg). 4) Peripheral blood white blood cell count greater than 12 × 109/L or less than 4 × 109/L, or immature white blood cells greater than 10%, but other reasons that can cause the aforementioned acute abnormal changes should be ruled out. B. Grouping of SIRS patients: The diagnostic criteria in this section refer to the 2021 Surviving sepsis campaign guidelines
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28th day death group | – | Other: no interventionPatient dies within 28 days after hospitalization |
| non-28th day death group | – | Other: no interventionThe patient does not die within 28 days after hospitalization |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study site and population included patients with systemic inflammatory response syndrome caused by "infectious factors" who were admitted to the Emergency Department of the First Hospital of Jilin University from January 1, 2023 to December 31, 2027. The screening criteria for the study population were patients with "systemic inflammatory response syndrome" caused by sensory factors who were continuously registered and treated at the Emergency Department of the First Affiliated Hospital of Jilin University from January 1, 2023 to December 31, 2027.
Key inclusion criteria (1 listed)
- Age greater than or equal to 15 years old; 2) A patient who sought medical treatment at the Emergency Department of Jilin University First Hospital due to "systemic inflammatory response syndrome" (see relevant concepts and definitions in section 4.2 below). 3) Within 24 hours of seeking medical attention, evidence of "infection" can be clearly detected through imaging and laboratory examinations. Patients can be diagnosed and classified as at least one of the following conditions: respiratory system infection, digestive system infection, urinary system infection, blood borne infection, or skin soft tissue infection.
Key exclusion criteria (1 listed)
- pregnant and lactating women; 2) Active pulmonary tuberculosis; 3) Patients who do not agree to participate in this study.
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 |
|---|---|---|
| no interventionno intervention | Other | 28th day death group, non-28th day death group |
Primary outcome
The patient dies within 28 days after hospitalization
Time frame: within 28 days after hospitalization
The patient dies within 28 days after hospitalization
The patient does not die within 28 days after hospitalization
Time frame: within 28 days after hospitalization
The patient does not die within 28 days after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
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 The First Hospital of Jilin University.
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 26 Oct 2023. 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?
Results are not available in the source record.
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?
The patient dies within 28 days after hospitalization (time frame: within 28 days after hospitalization). The study lists 2 primary outcomes in all. 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 26 Oct 2023.