Assessment of Disease Severity, Progression and Treatment in Infected Patients Presenting to the Emergency Department

NCT03992794 | Completed

• 1 other identifier: 18/081-E
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 3

Brief Summary

The results of the SIDED study (doi: 10.1186 / s13054-019-2329-5) showed that MR-proADM can be a good biomarker to establish the prognosis of patients attended in the emergency department (ED) due to suspected infection. MR-proADM could be useful to help making-decision regarding admission or discharge of patients, and in addicion to determine the need to apply or not early antibiotic treatment. However, despite analyzing more than 2,500 patients from 8 countries, the original study had a number of limitations. Samples of the biomarkers were retrospectively analyzed in a device that is not routinely used in the ED (Kryptor, Thermo Fisher, Germany). The availability of MR-proADM at the point of care could facilitate its widespread use in all EDs. This study is conducted to confirm the results of the SIDED study by using a device at the patient's bedside that allows the quantitative determination of the MR-proADM and procalcitonin biomarkers, instead of using a Kryptor platform.

Conditions

Sepsis

Keywords

Sepsis; Emergency department; Sepsis biomarkers; MR-proADM

Outcome Measures

Primary Outcomes (3)

• Mortality

  Mortality

  28 days

• ICU admission

  Intensive care admission of the attended patient

  28 days

• Time of antibiotic administration

  Length of time from initial presentation at the ED to the first dose of antibiotics being administered.

  24 hrs

Secondary Outcomes (2)

• Disease progression

  28 days

• Hospital readmission

  28 days

Study Arms (1)

Total patients

Consecutive patients presenting to the ED with either a suspected or documented infection in which blood samples were taken during routine. An extra blood sample was taken to measure PCT \& MR-proADM using the Samsung IB10 point of care assay.

Diagnostic Test: Measurement of MR-proADM

Interventions

Measurement of MR-proADM DIAGNOSTIC_TEST

It is an observational study. The only intervention was the measure of MR-proADM, but no clinical decision was made based on its value, since the physician attending the patient did´n know the value of MR-proADM

Total patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ED with either a suspected or documented infection

You may qualify if:

• Age ≥ 18 years
• Consecutive patients presenting to the ED with either a suspected or documented infection
• Blood samples taken during routine use only
• Patient has given written informed consent

You may not qualify if:

• Age \< 18 years
• Patients where no blood samples were taken for routine purposes
• Those with no suspicion of infection
• Pregnancy
• Refusal to participate
• Patient has already participated in a similar clinical trial

Sponsors & Collaborators

• Juan González-del Castillo: lead
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (3)

Hospital Universitario General de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospita Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (1)

• Saeed K, Wilson DC, Bloos F, Schuetz P, van der Does Y, Melander O, Hausfater P, Legramante JM, Claessens YE, Amin D, Rosenqvist M, White G, Mueller B, Limper M, Callejo CC, Brandi A, Macchi MA, Cortes N, Kutz A, Patka P, Yanez MC, Bernardini S, Beau N, Dryden M, van Gorp ECM, Minieri M, Chan L, Rood PPM, Del Castillo JG. The early identification of disease progression in patients with suspected infection presenting to the emergency department: a multi-centre derivation and validation study. Crit Care. 2019 Feb 8;23(1):40. doi: 10.1186/s13054-019-2329-5.

  PMID: 30736862 RESULT

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Juan Gonzalez del Castillo, MD, phD

  Head of Infection Disease Group of Spanish Emergency Medicine Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: HEAD OF INFECTION DISEASE GROUP OF SPANISH EMERGENCY MEDICINE SOCIETY

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 20, 2019
• Study Start: March 15, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)