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

Sponsor
Brahms AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03770533
Collaborator
(none)
200
Enrollment
4
Locations
2
Arms
11.9
Actual Duration (Months)
50
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MR-proADM guided
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Dec 11, 2019
Actual Study Completion Date :
Dec 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: MR-proADM guided

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
No Intervention: Standard Care

Outcome Measures

Primary Outcome Measures

  1. Rate of patients admitted to the hospital [14 days]

Secondary Outcome Measures

  1. 28 days all-cause hospital re-admission (corrected for mortality) [28 days]

  2. Number of patients re-presenting to the ED within 28 days [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
2 Hospital Universitario de Bellvitge Barcelona Spain 08907
3 Hospital Clínico San Carlos Madrid Spain 28040
4 Hospital Virgen Macarena Sevilla Spain 41009

Sponsors and Collaborators

  • Brahms AG

Investigators

  • Principal Investigator: Juan Gonzalez del Castillo, Hospital Clinico San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brahms AG
ClinicalTrials.gov Identifier:
NCT03770533
Other Study ID Numbers:
  • IDEAL pilot
First Posted:
Dec 10, 2018
Last Update Posted:
Dec 12, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases

Study Results

No Results Posted as of Dec 12, 2019