SepsisBIPROSNCT05842980
BIomarkers to Predict the Outcomes of Sepsis
An observational study of Sepsis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- sepsis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2025
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion of patients diagnosed with sepsis
Who may be able to join
- -
- The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the International Consensus on Sepsis and Sepsis Shock (Sepsis-3.0) are:
- Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points;
- Sepsis-3.0 diagnostic criteria for septic shock: Sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmHg, and serum lactate level>2mmol/L (18mg/dL).
- Age 18 to 85 years old
Who cannot join
- patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (<0.5 × 109/L), malignant tumors or other serious chronic diseases (heart failure, Liver failure, end-stage renal disease, etc.);
- Receiving glucocorticoid treatment;
- Pregnancy;
- Refuse enrollment or give up active treatment. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Ji'nan, Shandong, 250012
Jiaojiao Pang, Dr, 18560089129, jiaojiaopang@126.com
About this study
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
Read the detailed description
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. There are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. According to Lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. Surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. The World Health Organization (WHO) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. With the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
- Conditions
- Sepsis
- Being tested
- sepsis
- Keywords
- sepsis, biomarker
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sepsisOther
collect 5ml blood from patient
| Study group | Role | What they receive |
|---|---|---|
| sepsis | sepsis patients Receives: Other: sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
28d all-cause mortality
28d all-cause mortality
Measured: 28 days
Secondary outcomes (16)
Incidence of secondary infection
recurrence, double infection and new infection
Measured: Day 0 to 28
ICU stays
ICU stays
Measured: 90 days
Hospital stays
Hospital stays
Measured: 90 days
re-hospitalization rate
re-hospitalization rate
Measured: 90 days
SOFA score
SOFA score
Measured: at days -1, 7, 14 and 28
all-cause mortality
all-cause mortality
Measured: 90 days
ICU mortality
ICU mortality
Measured: 90 days
28-day ventilator-free days
28-day ventilator-free days
Measured: 28-day
28-day ICU-free days
28-day ICU-free days
Measured: 28-day
28-day CRRT-free days
28-day CRRT-free days
Measured: 28-day
28-day Vasoactive agents-free days
28-day Vasoactive agents-free days
Measured: 28-day
Septic shock
The incidence of septic shock
Measured: 28-day
Sepsis heart injury
Ejection fraction<50% and left ventricular ejection fraction (LVEF) decreased by 10% from baseline，changes in biomarkers such as CKMB、cTNI caused by sepsis
Measured: 28-day
Sepsis renal injury
Changes in biomarkers such as creatinine caused by sepsis
Measured: 28-day
Sepsis liver injury
Changes in biomarkers such as ALT，AST caused by sepsis
Measured: 28-day
Out-of-hospital mortality rate
Mortality rate within one year after discharge
Measured: Discharge for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (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 Qilu Hospital of Shandong 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842980
- Sponsor's protocol ID
- BIPROS
- Acronym
- BIPROS
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIomarkers to Predict the Outcomes of Sepsis
- ClinicalTrials.gov ID
- NCT05842980
- Acronym / sponsor ID
- BIPROS / BIPROS
- Conditions
- Sepsis
- Keywords
- sepsis, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 May 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 is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
Detailed description
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. There are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. According to Lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. Surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. The World Health Organization (WHO) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. With the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | Other: sepsissepsis patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion of patients diagnosed with sepsis
Key inclusion criteria (5 listed)
- -
- The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the International Consensus on Sepsis and Sepsis Shock (Sepsis-3.0) are:
- Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points;
- Sepsis-3.0 diagnostic criteria for septic shock: Sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmHg, and serum lactate level>2mmol/L (18mg/dL).
- Age 18 to 85 years old
Key exclusion criteria (4 listed)
- patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (<0.5 × 109/L), malignant tumors or other serious chronic diseases (heart failure, Liver failure, end-stage renal disease, etc.);
- Receiving glucocorticoid treatment;
- Pregnancy;
- Refuse enrollment or give up active treatment. -
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 |
|---|---|---|
| sepsiscollect 5ml blood from patient | Other | sepsis |
Primary outcome
28d all-cause mortality
Time frame: 28 days
28d all-cause mortality
16 secondary outcomes
Incidence of secondary infection
Time frame: Day 0 to 28
ICU stays
Time frame: 90 days
Hospital stays
Time frame: 90 days
re-hospitalization rate
Time frame: 90 days
SOFA score
Time frame: at days -1, 7, 14 and 28
all-cause mortality
Time frame: 90 days
ICU mortality
Time frame: 90 days
28-day ventilator-free days
Time frame: 28-day
28-day ICU-free days
Time frame: 28-day
28-day CRRT-free days
Time frame: 28-day
28-day Vasoactive agents-free days
Time frame: 28-day
Septic shock
Time frame: 28-day
Sepsis heart injury
Time frame: 28-day
Sepsis renal injury
Time frame: 28-day
Sepsis liver injury
Time frame: 28-day
Out-of-hospital mortality rate
Time frame: Discharge for one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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CT for Personalized Mechanical Ventilation
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
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 Qilu Hospital of Shandong University at 1 site in 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 5 inclusion and 4 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 6 May 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 China. 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 Jiaojiao Pang, Dr (18560089129, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28d all-cause mortality (time frame: 28 days). 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 6 May 2023.