Establishment of Early Diagnosis and Monitoring Model for Sepsis Patients

NCT04974411 | Unknown DMC

• 1 other identifier: XJTU1AF-CRF-2020-003
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, although the clinical treatment of sepsis has been greatly improved, it is still an important cause of death in ICU patients, and seriously threatens human health. Its predictive biomarkers have become one of the bottlenecks in the field of disease diagnosis, treatment and development of effective drugs to reduce incidence rate and mortality. This will eventually become the key point of treatment for patients with sepsis. In the early stage, the investigators have established a single center sepsis database and sepsis animal model, and made a preliminary exploration on the mechanism and treatment of sepsis. Based on the previous results, this study intends to create a national multi center sepsis apparent database and sample bank, collect the data of sepsis patients' injury characteristics, clinical characteristics, biochemical indicators, micro multidimensional and omics results, etiological characteristics, etc., and integrate them. Using big data combined with machine learning method, the early warning and real-time course monitoring model of traumatic sepsis is established. The completion of this project can achieve early warning of sepsis, real-time monitoring of the progress of the disease, early rational allocation of medical care, and reduce the mortality of sepsis patients.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• mortality

  Patient in-hospital mortality and all-cause deaths that occurred during follow-up

  From date of first record until the date of death from any cause, assessed up to 24 months

Secondary Outcomes (4)

• Average length of stay

  From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• length of stay in the intensive care unit

  From the first day of admission to the end of the ICU,assessed up to 6 months

• the time of using antibiotic

  From the first day of admission to the end of the ICU,assessed up to 6 months

• the number of organ dysfunction

  From the first day of admission to the end of the ICU,assessed up to 6 months

Study Arms (3)

Infection

Patients diagnosed with infection but did not reach the sepsis marker.

Other: infection

sepsis

The patient was diagnosed with sepsis but did not develop septic shock

Other: infection; Other: sepsis

sepsis shock

The patient was diagnosed with sepsis shock

Other: infection; Other: sepsis

Interventions

infection OTHER

this study had two observation cohorts, one that observed sepsis in the presence of infection; the other cohort was monitored during sepsis until septic shock appeared

Infection; sepsis; sepsis shock

sepsis OTHER

this study had two observation cohorts, one that observed sepsis in the presence of infection; the other cohort was monitored during sepsis until septic shock appeared

sepsis; sepsis shock

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with infectious inflammation or sepsis

You may qualify if:

• Patients diagnosed with an infectious disease or Sepsis patients meeting the diagnostic criteria for sepsis 3.0 (determined by two doctors with senior professional titles)
• Older than 16 years and younger than 60 years
• Agree to cooperate with the investigation and sign the informed consent

You may not qualify if:

• The infection was preexisting with clinically diagnosed organ insufficiency or failure
• Hematological disorders predate infection
• Sepsis is preceded by a serious infectious disease
• Long-term use of immunosuppressant or immunodeficiency patients.
• A pregnant woman

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Tang-Du Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• LanZhou University: collaborator
• The Fourth People's Hospital of Nanning: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Liu Chang, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Miao RunChen, MD

CONTACT

0086-18229097849; miaozao@126.com

Liu Tong, Master

CONTACT

0086-15129935253; 1656044911@qq.com

Study Design

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

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 23, 2021
• Study Start: February 2, 2021
• Primary Completion: February 28, 2024
• Study Completion: March 20, 2024
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

CN (1)