NCT05108883

Risk Stratification Using Midregional Proadrenomedullin in the ED

IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Brahms AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Presenting With Suspicion of Infection to the ED

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2021-11-05
• Last updated: 2025-04-01

Locations

9 sites across 4 countries: France, Italy, Spain, United Kingdom