NCT06724120

Brief Summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. It is one of the leading causes of death and disability worldwide, with an inpatient mortality rate of 10-20%. Sepsis is a severe complication in critically ill patients and can lead to septic shock and multiple organ dysfunction syndrome (MODS), usually triggered by severe trauma, surgery, and infections. Despite the availability of advanced diagnostic, therapeutic, and monitoring technologies, the incidence and mortality of sepsis remain high, posing a significant global challenge to the medical community. Over 49 million people worldwide develop sepsis annually, with approximately 11 million deaths, resulting in a mortality rate of about 15%-25%. This study aims to develop a prognosis prediction model for sepsis patients using a neural network architecture (Transformer algorithm), based on time-series data. The primary outcome observed is the mortality outcome of sepsis patients. The goal of the research is to enhance the early identification of high-risk sepsis patients, thereby optimizing the timing of sepsis treatment and intervention and improving the accuracy of prognosis prediction for sepsis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,641

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

November 30, 2024

Last Update Submit

December 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biomarker level

    Including inflammatory markers (such as C-reactive protein (CRP), interleukins (IL-6, IL-10), and procalcitonin (PCT)) and metabolic markers (such as lactate levels and arterial blood gas pH values) for sepsis prognostic analysis.

    5 Years

Secondary Outcomes (3)

  • SOFA score

    5 Years

  • Length of ICU stay

    5 Years

  • APACHE II score

    5 Years

Study Arms (2)

Survival Group

Other: No interventions

Non-survival Group

Other: No interventions

Interventions

No interventions

Non-survival GroupSurvival Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective analysis of clinical data of patients diagnosed with sepsis at West China Hospital of Sichuan University from January 2020 to December 2023. Review and summarize the baseline data of patients (including age, gender, comorbidities, history of malignant tumors, lesion location, pathological type, etc.), occurrence of serious complications, total length of hospital stay, survival time, and construct a time-series based mortality risk prognosis prediction model for sepsis patients.

You may qualify if:

  • Patients clinically diagnosed with sepsis at West China Hospital of Sichuan University from January 2020 to December 2023

You may not qualify if:

  • Under the age of 18;
  • Gender unknown;
  • Incorrect or invalid discharge diagnosis;
  • The hospitalization time is less than 24 hours;
  • Data information is missing by more than 30%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Zhang

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Chi Zhang

Study Record Dates

First Submitted

November 30, 2024

First Posted

December 9, 2024

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations