Early Prediction of Sepsis (ExPRESS)

AlgoDx

Status: Completed

Conditions: Sepsis

Treatments: Device: Unblinded AlgoDx Sepsis Prediction Algorithm; Other: Blinded AlgoDx Sepsis Prediction Algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04570618

SEP-SE-02

Details and patient eligibility

About

In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patient (age ≥18 years).
2. Patient is admitted to the ICU during the recruitment period of the trial.

Exclusion criteria

1. Patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days.
2. Patient is known to be pregnant.
3. Death is deemed imminent and inevitable, at the investigator's discretion.
4. Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision
5. Patient has previously been enrolled in this trial.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

Standard of Care

Sham Comparator group

Description:

Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines.

Treatment:

Other: Blinded AlgoDx Sepsis Prediction Algorithm

Standard of Care + AlgoDx Sepsis Prediction Algorithm

Experimental group

Description:

Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines, and sepsis prediction algorithm alerts are unblinded to clinical staff.

Treatment:

Device: Unblinded AlgoDx Sepsis Prediction Algorithm