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

Not Applicable

Completed

• Conditions: Patients Presenting With Suspicion of Infection to the ED
• Interventions: Other: MR-proADM guided

• Registration Number: NCT03770533
• Lead Sponsor: Brahms AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Study Start: 2018-12-14
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR-proADM guided	MR-proADM guided	-

Primary Outcome Measures

Name	Time	Method
Rate of patients admitted to the hospital	14 days

Secondary Outcome Measures

Name	Time	Method
Number of patients re-presenting to the ED within 28 days	28 days
28 days all-cause hospital re-admission (corrected for mortality)	28 days

Trial Locations

Locations (4)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain