Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning (ABC)

Amsterdam UMC, location VUmc

Status

Enrolling

Conditions

Artificial Intelligence

Microbiology

Machine Learning

Randomized Controlled Trial

Emergency Service, Hospital

Treatments

Device: Blood culture prediction tool

Study type

Interventional

Funder types

Other

Identifiers

NCT06163781

NL81971.000.22

Details and patient eligibility

About

The goal of this clinical trial is to study whether the use of our blood culture prediction tool is non-inferior to current practice and if it can improve certain outcomes in all adult patients presenting to the emergency department with a clinical indication for a blood culture analysis (according to the treating physician). The primary endpoint is 30-day mortality. Key secondary outcomes are:

hospital admission rates
in-hospital mortality
hospital length-of-stay. In the intervention group, the physician will follow the advice of our blood culture prediction tool.

In the comparison group all patients will undergo a blood culture analysis.

Full description

Rationale: The overuse of blood cultures in emergency departments leads to low yields and high numbers of contaminated cultures, which is associated with increased diagnostics, antibiotic usage, prolonged hospitalisation, and mortality. Ideally, blood cultures would only be performed in patients with a high risk for a positive culture. The investigators have developed a machine learning model to predict the outcome of blood cultures in the ED. Retrospective and prospective validation of the tool in various settings show that it can be used to reduce the number of blood culture analyses by at least 30% and help avoid the hidden costs of contaminated cultures.

Objective: This study aims to investigate whether the use of our blood culture prediction tool is non-inferior to current practice and if it can improve certain outcomes.

Study design: A randomized controlled non-inferiority trial. Study population: All adult patients presenting to the emergency department with a clinical indication for a blood culture analysis (according to the treating physician).

Intervention: In the control group, all patients will undergo a blood culture analysis. In the intervention group, the physician will follow the advice of our blood culture prediction tool. If the chance of a positive blood culture is < 5%, the blood culture analysis will be cancelled and the sample destroyed. If the change of a positive blood culture is > 5%, the blood culture analysis will be performed as usual.

Main study parameters/endpoints: The primary endpoint is 30-day mortality, for which the investigators aim to show non-inferiority. Key secondary outcomes, for which the investigators also aim to show non-inferiority, are hospital admission rates, in-hospital mortality, and hospital length-of-stay.

Enrollment

7,584 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age >= 18 years
Have a clinical indication for a blood culture analysis (according to the treating physician)
Have sufficient data recorded (laboratory results and vital sign measurements) for a prediction to be made (at least 20% of the needed parameters)

Exclusion criteria

Central Venous Line (CVL) or Peripherally Inserted Central Catheter (PICC) in situ
Neutrophil count < 0.5 * 109/L
Candidemia or S. aureus bacteraemia in the past 3 months.
Most likely diagnosis of endocarditis/spondylodiscitis/infected prosthetic material
Pregnant or breastfeeding patients
Not capable of giving informed consent