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Not yet recruiting NCT07543497

Performance and Impact of the Sepsis ImmunoScore

— Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sepsis ImmunoScore.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study

Overview

The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.

Interventions

  • Diagnostic test Sepsis ImmunoScore
    The Sepsis ImmunoScore is a risk stratification tool that uses Artificial Intelligence/Machine Learning to aid in the identification of patients likely to have or progress to sepsis within 24 hours of assessment.

Primary outcome measures

  • Sepsis diagnosis [Time frame: 24 hours]
  • SEP-1 bundle compliance [Time frame: through study completion, an average of 1 year]
  • Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (6)
  • Time to antibiotic administration [Time frame: through study completion, an average of 1 year]
  • Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis [Time frame: through study completion, an average of 1 year]
  • Hospital length of stay [Time frame: through study completion, an average of 1 year]
  • ICU length of stay [Time frame: through study completion, an average of 1 year]
  • Total charges [Time frame: through study completion, an average of 1 year]
  • In-hospital mortality rate [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Adult (age 18 years or older) patients presenting to hospitals and emergency departments of medical institutions across the United States.
  • Adult (age 18 years or older) patients suspected of sepsis.

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07543497 · CLN-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗