BIomarkers to Predict the Outcomes of Sepsis

NCT05842980 | Unknown DMC

• 1 other identifier: BIPROS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

sepsis; biomarker

Outcome Measures

Primary Outcomes (1)

• 28d all-cause mortality

  28d all-cause mortality

  28 days

Secondary Outcomes (16)

• Incidence of secondary infection

  Day 0 to 28

• ICU stays

  90 days

• Hospital stays

  90 days

• re-hospitalization rate

  90 days

• SOFA score

  at days -1, 7, 14 and 28

Study Arms (1)

sepsis

sepsis patients

Other: sepsis

Interventions

sepsis OTHER

collect 5ml blood from patient

sepsis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion of patients diagnosed with sepsis

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Ji'nan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5ml blood from sepsis patients

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiaojiao Pang, Dr

CONTACT

18560089129; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

CN (1)