Risk Stratification Using Midregional Proadrenomedullin in the ED

March 27, 2025 updated by: Brahms AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

463

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75651
        • Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université
  • Italy
      • Roma, Italy, 00133
        • Policlinico Tor Vergata
      • Udine, Italy, 33100
        • Hospital Santa Maria Della Misericordia
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Seville, Spain, 41009
        • Hospital Virgen de la Macarena
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias (HUCA)
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Hampshire Hospitals NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care arm
decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols
Experimental: MR-proADM guided arm
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of out-patients re-presenting to the ED
Time Frame: 5 days
Number of out-patients re-presenting to the ED
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brahms AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Actual)

November 7, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDEAL+ Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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