BIomarkers to Predict the Outcomes of Sepsis

Last updated: April 24, 2023
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

sepsis

Clinical Study ID

NCT05842980
BIPROS
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rdedition 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 aSequential 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 maintainaverage arterial pressure ≥ 65mmHg, and serum lactate level>2mmol/L (18mg/dL).
  3. Age 18 to 85 years old

Exclusion

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 Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: sepsis
Phase:
Study Start date:
June 01, 2020
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Qilu Hospital of Shandong University

    Ji'nan, Shandong 250012
    China

    Active - Recruiting

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