Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
3010

Summary

Conditions
  • Infection
  • Sepsis
Type
Observational
Design
Observational Model: CohortTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is an observational, cross-sectional (single-gate) study comparing the results of the index test (MDW) against different reference standards (operational definitions). One of these references identifies a situation when IV antibiotics need to start (i.e. sepsis diagnosis) and the other, a situa...

This is an observational, cross-sectional (single-gate) study comparing the results of the index test (MDW) against different reference standards (operational definitions). One of these references identifies a situation when IV antibiotics need to start (i.e. sepsis diagnosis) and the other, a situation when they need to be discontinued (i.e. clinical improvement). One reference standard will be Sepsis 3 definition and will be operationalised in ED using qSOFA ? 2. This is used in ED as a bedside score to identify patients with suspected sepsis. As part of the exploratory objectives for this ED dataset, sepsis will be operationalised using other common scores (SOFA, NEWS2, REDS, and Simplified-MISSED scores), and also against the reference standard for confirming septicaemia (blood culture results). The second reference standard will be expert clinical criteria. Antimicrobial stewardship groups and care team review antibiotic treatments for all inpatients at regular intervals. Decisions on whether discontinuation (due to clinical improvement) is indicated is ultimately based on clinical criteria. As part of the exploratory objectives for the dataset of in-patients, sepsis will be operationalised using the results of blood cultures. Also, different subpopulations will be described on the basis of MDW levels: Hospitalised patients admitted through ED but not in the sepsis pathway. Hospital Acquired Infections (HAI), surgical operations, and IV antibiotic treatment modification due to lack of clinical improvement and/or antibiotic resistance. Non-bacterial causes of septic syndrome (i.e. surgical tissue injury, myocardial infraction, pancreatitis, pulmonary-thromboembolism, influenza, RSV, autoimmune and neoplastic processes).

Tracking Information

NCT #
NCT04300530
Collaborators
Not Provided
Investigators
Not Provided