Risk Stratification Using Midregional Proadrenomedullin in the ED

NCT05108883 | Completed

• 1 other identifier: IDEAL+ Study
• Study Type: interventional
• Target: 463
• Locations: 4 countries
• Sites: 9

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.

Conditions

Patients Presenting With Suspicion of Infection to the ED

Outcome Measures

Primary Outcomes (1)

• Number of out-patients re-presenting to the ED

  Number of out-patients re-presenting to the ED

  5 days

Study Arms (2)

standard care arm

NO INTERVENTION

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols

MR-proADM guided arm

EXPERIMENTAL

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

Interventions

MR-proADM KRYPTOR DEVICE

MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

MR-proADM guided arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients presenting to the ED with suspicion of infection
• Age ≥18 years
• Written Informed Consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Brahms AG: lead

Study Sites (9)

Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université

Paris, 75651, France

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Hospital Santa Maria della Misericordia

Udine, 33100, Italy

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 5, 2021
• Study Start: October 14, 2021
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

FR (1); GB (2); ES (4); IT (2)