NCT05108883CompletedNot Applicable
IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study
Brahms AG18 sites in 4 countries463 target enrollmentStarted: October 14, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 463
- Locations
- 18
- Primary Endpoint
- Number of out-patients re-presenting to the ED
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of out-patients re-presenting to the ED
Time Frame: 5 days
Number of out-patients re-presenting to the ED
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (18)
Loading locations...
Similar Trials
Completed
Not Applicable
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot StudyPatients Presenting With Suspicion of Infection to the EDNCT03770533Brahms AG200
Completed
Not Applicable
The Copenhagen Triage AlgorithmTriageNCT02698319Herlev Hospital50,000
Completed
Not Applicable
Reducing Length of Stay in the Emergency DepartmentLength of StayNCT03185533National Taiwan University Hospital Hsin-Chu Branch72,000
Recruiting
Not Applicable
ED Adaptive Staffing StudyEmergency MedicineWell-Being, PsychologicalNCT05937763Oak Valley Health5,917
Completed
Not Applicable
Prevalence of Presenting Diseases for Elderly Patients Admitted to Emergency DepartmentGeriatric DisorderNCT02734381Adiyaman University Research Hospital36,369