BIomarkers to Predict the Outcomes of Sepsis (BIPROS)

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jiaojiao Pang, Dr; Phone Number: 18560089129; Email: jiaojiaopang@126.com

Study Locations

• China
  • Shandong
    • Ji'nan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Jiaojiao Pang, Dr; Phone Number: 18560089129; Email: jiaojiaopang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Inclusion of patients diagnosed with sepsis

Description

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. -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sepsis; sepsis patients	Other: sepsis; collect 5ml blood from patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28d all-cause mortality	28d all-cause mortality	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: BIPROS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No