BIomarkers to Predict the Outcomes of Sepsis

Sepsis Clinical Trial

— BIPROS  

Official title:

BIomarkers to Predict the Outcomes of Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842980
• Other study ID #: BIPROS
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang, Dr
• Phone: 18560089129
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

- 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:

1. Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) = 2 points;

2. 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).

3. Age 18 to 85 years old

Exclusion Criteria:

1. 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.);

2. Receiving glucocorticoid treatment;

3. Pregnancy;

4. Refuse enrollment or give up active treatment. -

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• sepsis
collect 5ml blood from patient

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Ji'nan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28d all-cause mortality	28d all-cause mortality	28 days
Secondary	Incidence of secondary infection	recurrence, double infection and new infection	Day 0 to 28
Secondary	ICU stays	ICU stays	90 days
Secondary	Hospital stays	Hospital stays	90 days
Secondary	re-hospitalization rate	re-hospitalization rate	90 days
Secondary	SOFA score	SOFA score	at days -1, 7, 14 and 28
Secondary	all-cause mortality	all-cause mortality	90 days
Secondary	ICU mortality	ICU mortality	90 days
Secondary	28-day ventilator-free days	28-day ventilator-free days	28-day
Secondary	28-day ICU-free days	28-day ICU-free days	28-day
Secondary	28-day CRRT-free days	28-day CRRT-free days	28-day
Secondary	28-day Vasoactive agents-free days	28-day Vasoactive agents-free days	28-day
Secondary	Septic shock	The incidence of septic shock	28-day
Secondary	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	28-day
Secondary	Sepsis renal injury	Changes in biomarkers such as creatinine caused by sepsis	28-day
Secondary	Sepsis liver injury	Changes in biomarkers such as ALT,AST caused by sepsis	28-day
Secondary	Out-of-hospital mortality rate	Mortality rate within one year after discharge	Discharge for one year