Back to resultsIdentifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study (IDEAL)
Primary Purpose
Patients Presenting With Suspicion of Infection to the ED
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MR-proADM guided
Sponsored by
About this trial
This is an interventional other trial for Patients Presenting With Suspicion of Infection to the ED
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
Sites / Locations
- Hospital Universitario Central de Asturias
- Hospital Universitario de Bellvitge
- Hospital Clínico San Carlos
- Hospital Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
MR-proADM guided
Standard Care
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients admitted to the hospital
Secondary Outcome Measures
28 days all-cause hospital re-admission (corrected for mortality)
Number of patients re-presenting to the ED within 28 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03770533
Brief Title
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study
Acronym
IDEAL
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brahms AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Presenting With Suspicion of Infection to the ED
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR-proADM guided
Arm Type
Other
Arm Title
Standard Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
MR-proADM guided
Intervention Description
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 Outcome Measure Information:
Title
Rate of patients admitted to the hospital
Time Frame
14 days
Secondary Outcome Measure Information:
Title
28 days all-cause hospital re-admission (corrected for mortality)
Time Frame
28 days
Title
Number of patients re-presenting to the ED within 28 days
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Gonzalez del Castillo
Organizational Affiliation
Hospital Clinico San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33906810
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.
Results Reference
derived
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Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study
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