Risk Stratification Using Midregional Proadrenomedullin in the ED

Sponsor

Brahms AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05108883

Collaborator

(none)

452

Enrollment

Locations

Arms

18.5

Anticipated Duration (Months)

113

Patients Per Site

6.1

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 safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.

Condition or Disease	Intervention/Treatment	Phase
Patients Presenting With Suspicion of Infection to the ED	Device: MR-proADM KRYPTOR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

452 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study

Actual Study Start Date :

Oct 14, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard care arm decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols
Experimental: MR-proADM guided arm decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels	Device: MR-proADM KRYPTOR MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

Arm

Intervention/Treatment

No Intervention: standard care arm

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment and usual protocols

Experimental: MR-proADM guided arm

decision whether a patient will be hospitalized or be treated as out-patient is based on routine clinical assessment, usual protocols and MR-proADM levels

Device: MR-proADM KRYPTOR

MR-proADM ≤ 0.87 nmol/L together with routine clinical evaluation identifies patients with low disease severity who do not need to be hospitalized

Outcome Measures

Primary Outcome Measures

Number of out-patients re-presenting to the ED [5 days]
Number of out-patients re-presenting to the ED

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive patients presenting to the ED with suspicion of infection
Age ≥18 years
Written Informed Consent obtained

Exclusion Criteria:

Patients with SARS-COV-2 infection
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 whose 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 abusive 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 (HUCA)	Oviedo	Asturias	Spain	33011
2	Hospital Clinic	Barcelona		Spain	08036
3	Hospital Clinico San Carlos	Madrid		Spain	28040
4	Hospital Virgen de la Macarena	Seville		Spain	41009

Sponsors and Collaborators

Brahms AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brahms AG

ClinicalTrials.gov Identifier:

NCT05108883

Other Study ID Numbers:

IDEAL+ Study

First Posted:

Nov 5, 2021

Last Update Posted:

Jun 16, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Study Results

No Results Posted as of Jun 16, 2022