Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06163781

Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning: a Randomized Controlled Trial

Led by Amsterdam UMC, location VUmc · Updated on 2024-05-07

7584

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether using a blood culture prediction tool based on machine learning is as effective as current practices for adult patients in the emergency department who need a blood culture analysis. The study focuses on patients who have a clinical indication for blood cultures as determined by their treating physician. The primary goal is to compare 30-day mortality rates, with additional outcomes including hospital admission rates, in-hospital mortality, and length of hospital stay. Participants will be randomly assigned to one of two groups. In the intervention group, doctors will use the blood culture prediction tool to decide whether to perform the blood culture test; if the predicted chance of a positive result is less than 5%, the test will be cancelled. In the control group, all patients will undergo blood culture analysis as usual. This randomized controlled trial aims to see if the prediction tool can reduce unnecessary blood cultures and associated issues without increasing risks. During the study, patients will be monitored for 30 days to assess mortality, with hospital admission, in-hospital mortality, and length of stay tracked up to 90 days. Data such as laboratory results and vital signs are collected to support predictions. Safety and outcomes will be carefully reviewed to determine if the tool offers a non-inferior approach compared to standard blood culture testing. Participation duration and follow-up will be based on these timelines to capture relevant clinical outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical indication for blood culture analysis according to the treating physician
  • Sufficient recorded data available (at least 20% of required laboratory results and vital signs) for prediction
Not Eligible

You will not qualify if you...

  • Presence of Central Venous Line (CVL) or Peripherally Inserted Central Catheter (PICC)
  • Neutrophil count less than 0.5 x 10^9/L
  • History of candidemia or Staphylococcus aureus bacteraemia in the past 3 months
  • Likely diagnosis of endocarditis, spondylodiscitis, or infected prosthetic material
  • Pregnant or breastfeeding
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Up to 30 days

Participants undergo blood culture analysis based on either a machine learning prediction tool or the treating physician's decision.

1 visit (in-person) at the emergency department

Follow-up

Duration - Up to 90 days

Participants are monitored for outcomes including mortality, hospital admission, and length of stay following the blood culture analysis.

Follow-up assessments during hospital stay and up to 90 days after initial visit

Trial Site Locations

Total: 1 location

1

Amsterdam UMC - location AMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

P

Prabath WB Nanayakkara, MD, PhD

S

Sheena C Bhagirath, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Using machine learning to predict blood culture outcomes in the emergency department: a single-centre, retrospective, observational study.

Anneroos W Boerman, Michiel Schinkel, Lotta Meijerink...

https://pubmed.ncbi.nlm.nih.gov/34983764

Diagnostic stewardship for blood cultures in the emergency department: A multicenter validation and prospective evaluation of a machine learning prediction tool.

Michiel Schinkel, Anneroos W Boerman, Frank C Bennis...

https://pubmed.ncbi.nlm.nih.gov/35853298

Appropriate use of blood cultures in the emergency department through machine learning (ABC): study protocol for a randomised controlled non-inferiority trial.

Anuschka Y van der Zaag, Sheena C Bhagirath, Anneroos W Boerman...

https://pubmed.ncbi.nlm.nih.gov/38821574