Risk Stratification Using Midregional Proadrenomedullin in the ED

Study Overview
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Brief Summary
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Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED. The rationale of this IDEAL+ study is to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.

Official Title
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IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study

Conditions
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Patients Presenting With Suspicion of Infection to the ED

Intervention / Treatment
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* Device: MR-proADM KRYPTOR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients presenting to the ED with suspicion of infection Age ≥18 years Written Informed Consent obtained Exclusion Criteria: Patients with SARS-COV-2 infection Recent major trauma or surgery End stage renal failure requiring dialysis Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure Patients whose source of infection always requires hospital admission or never requires hospital admission. Patients who cannot be discharged for other than medical reasons Patient participates in any other interventional clinical trial Patients with active abusive drug use Pregnant or lactating women Patients who are institutionalized by official or judicial order Dependents of the sponsor, the CRO, the study site or the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care arm<br>decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols | |
| Experimental: MR-proADM guided arm<br>decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels | Device: MR-proADM KRYPTOR<br>* MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of out-patients re-presenting to the ED | Number of out-patients re-presenting to the ED | 5 days |