- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770533
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study (IDEAL)
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08907
- Hospital Universitario de Bellvitge
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos
-
Sevilla, Spain, 41009
- Hospital Virgen Macarena
-
-
Asturias
-
Oviedo, Asturias, Spain, 33011
- Hospital Universitario Central de Asturias
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Standard Care
|
|
OTHER: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients admitted to the hospital
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28 days all-cause hospital re-admission (corrected for mortality)
Time Frame: 28 days
|
28 days
|
Number of patients re-presenting to the ED within 28 days
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan Gonzalez del Castillo, Hospital Clinico San Carlos
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDEAL pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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