Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study

NCT03770533 | Completed

• 1 other identifier: IDEAL pilot
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Patients Presenting With Suspicion of Infection to the ED

Outcome Measures

Primary Outcomes (1)

• Rate of patients admitted to the hospital

  14 days

Secondary Outcomes (2)

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

  28 days

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

  28 days

Study Arms (2)

MR-proADM guided

OTHER

Other: MR-proADM guided

Standard Care

NO INTERVENTION

Interventions

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

MR-proADM guided

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:

• 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

Sponsors & Collaborators

• Brahms AG: lead

Study Sites (4)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Related Publications (1)

• Gonzalez Del Castillo J, Clemente-Callejo C, Llopis F, Irimia A, Oltra-Hostalet F, Rechner C, Schwabe A, Fernandez-Rodriguez V, Sanchez-Mora C, Giol-Amich J, Prieto-Garcia B, Bardes-Robles I, Ortega-de Heredia MD, Garcia-Lamberechts EJ, Navarro-Bustos C; INFURG-SEMES investigators. Midregional proadrenomedullin safely reduces hospitalization in a low severity cohort with infections in the ED: a randomized controlled multi-centre interventional pilot study. Eur J Intern Med. 2021 Jun;88:104-113. doi: 10.1016/j.ejim.2021.03.041. Epub 2021 Apr 24.

  PMID: 33906810 DERIVED

Study Officials

• Juan Gonzalez del Castillo

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: December 14, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

ES (4)