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Risk Stratification Using Midregional Proadrenomedullin in the ED

NCT05108883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2025-04-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Brahms AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-11-07
Completion
2023-11-07

Countries

  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108883 on ClinicalTrials.gov