Clinical trial NCT03770533: Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study
Official title: Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Presenting With Suspicion of Infection to the ED
Lead sponsor: Brahms AG
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients admitted to the hospital
timeFrame: 14 days
Secondary outcomes:
measure: 28 days all-cause hospital re-admission (corrected for mortality)
timeFrame: 28 days
measure: Number of patients re-presenting to the ED within 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
affiliation: Hospital Clinico San Carlos
name: Juan Gonzalez del Castillo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.