Risk Stratification Using Midregional Proadrenomedullin in the ED

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-11-07

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.

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WITHDRAWN

Detailed Description

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Conditions

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Patients Presenting With Suspicion of Infection to the ED

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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standard care arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

MR-proADM guided arm

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

Group Type EXPERIMENTAL

MR-proADM KRYPTOR

Intervention Type DEVICE

MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

Interventions

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MR-proADM KRYPTOR

MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No