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

December 11, 2019 updated by: Brahms AG

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 14, 2018

Primary Completion (ACTUAL)

December 11, 2019

Study Completion (ACTUAL)

December 11, 2019

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (ACTUAL)

December 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IDEAL pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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