Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Nivaris Healthcare Pvt Ltd Bengaluru India
Eligibility
Inclusion criteria
Inclusion criteria: Adult, PICU or NICU admission in eligible care settings Suspected infection, deterioration or acute presentation requiring routine monitoring Adequate routine clinical data available Record permits clinician adjudication Consent / LAR consent where required by IEC
Exclusion criteria
Exclusion criteria: Materially incomplete records Sepsis status cannot be reliably adjudicated Duplicate or technically invalid records Investigator exclusion for scientific, ethical or administrative reasons Patient declines participation where consent is required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance of SepsiTrace for early prediction of sepsis, defined as the ability to identify patients at risk several hours prior to clinician-adjudicated sepsis diagnosis, using routinely collected hospital dataTimepoint: To evaluate the performance of SepsiTrace for early prediction of sepsis, defined as the ability to identify patients at risk several hours prior to clinician-adjudicated sepsis diagnosis, using routinely collected hospital data | — |
Secondary
| Measure | Time frame |
|---|---|
| To quantify the lead time between SepsiTrace risk prediction and clinician-adjudicated sepsis recognition; To assess the operational feasibility of real-world data acquisition in an Indian tertiary-care setting, including data completeness, frequency, and timelinessTimepoint: 1) Lead time between SepsiTrace high-risk output and clinician-adjudicated sepsis recognition; (2) Feasibility of structured data capture (completeness, frequency, timeliness | — |
Countries
India
Contacts
Public ContactAkshay HM
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH
Outcome results
None listed