Risk Stratification Using Midregional Proadrenomedullin in the ED

Not Applicable

Completed

• Conditions: Patients Presenting With Suspicion of Infection to the ED
• Interventions: Device: MR-proADM KRYPTOR

• Registration Number: NCT05108883
• Lead Sponsor: Brahms AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR-proADM guided arm	MR-proADM KRYPTOR	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

Primary Outcome Measures

Name	Time	Method
Number of out-patients re-presenting to the ED	5 days	Number of out-patients re-presenting to the ED

Trial Locations

Locations (9)

Hospital Universitario Central de Asturias (HUCA); 🇪🇸 Oviedo, Asturias, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Virgen de la Macarena; 🇪🇸 Seville, Spain

Hampshire Hospitals NHS Foundation Trust; 🇬🇧 Basingstoke, United Kingdom

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom

Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université; 🇫🇷 Paris, France

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Hospital Santa Maria della Misericordia; 🇮🇹 Udine, Italy