Patients Presenting With Suspicion of Infection to the ED
Conditions
Brief summary
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 provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.
Interventions
OTHERMR-proADM guided
MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized
Sponsors
Brahms AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients presenting to the ED with suspicion of infection * Age ≥18 years * Written Informed Consent obtained
Exclusion criteria
* 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 those 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 intravenous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients admitted to the hospital | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| 28 days all-cause hospital re-admission (corrected for mortality) | 28 days |
| Number of patients re-presenting to the ED within 28 days | 28 days |
Countries
Spain
Outcome results
None listed