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Completed

NCT Number: NCT05108883

Risk Stratification Using Midregional Proadrenomedullin in the ED

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.

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Key information

Conditions

Patients Presenting With Suspicion of Infection to the ED

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Number of out-patients re-presenting to the ED

    Time frame: 5 days

    Number of out-patients re-presenting to the ED

Sponsors and collaborators

Lead sponsor

Brahms AG

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2021
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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