Risk Stratification Using Midregional Proadrenomedullin in the ED

B·R·A·H·M·S

Status: Completed

Conditions: Patients Presenting With Suspicion of Infection to the ED

Treatments: Device: MR-proADM KRYPTOR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05108883

IDEAL+ Study

Details and patient eligibility

About

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.

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Consecutive patients presenting to the ED with suspicion of infection
2. Age ≥18 years
3. Written Informed Consent obtained

Exclusion criteria

1. Patients with SARS-COV-2 infection
2. Recent major trauma or surgery
3. End stage renal failure requiring dialysis
4. 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
5. Patients whose source of infection always requires hospital admission or never requires hospital admission.
6. Patients who cannot be discharged for other than medical reasons
7. Patient participates in any other interventional clinical trial
8. Patients with active abusive drug use
9. Pregnant or lactating women
10. Patients who are institutionalized by official or judicial order
11. Dependents of the sponsor, the CRO, the study site or the investigator

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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463 participants in 2 patient groups

standard care arm

No Intervention group

Description:

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols

MR-proADM guided arm

Experimental group

Description:

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

Treatment:

Device: MR-proADM KRYPTOR