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Completed

NCT Number: NCT03770533

Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot 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 provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.

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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

Hospital Universitario Central de Asturias, Oviedo, Principality of Asturias, Spain

Loading trial locations.

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

  • 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 those 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 intravenous 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 guided

Other

MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized

Primary outcomes

  1. Rate of patients admitted to the hospital

    Time frame: 14 days

Secondary outcomes

  1. 28 days all-cause hospital re-admission (corrected for mortality)

    Time frame: 28 days

  2. Number of patients re-presenting to the ED within 28 days

    Time frame: 28 days

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) - Pilot Study

Acronym: IDEAL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Dec 12, 2019

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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