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

NCT ID: NCT03770533

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Presenting With Suspicion of Infection to the ED

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MR-proADM guided

Group Type OTHER

MR-proADM guided

Intervention Type 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

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MR-proADM guided

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brahms AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Gonzalez del Castillo

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Locations

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Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Virgen Macarena

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33906810 (View on PubMed)

Other Identifiers

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IDEAL pilot

Identifier Type: -

Identifier Source: org_study_id