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

B

B·R·A·H·M·S

Status

Completed

Conditions

Patients Presenting With Suspicion of Infection to the ED

Treatments

Other: MR-proADM guided

Study type

Interventional

Funder types

Industry

Identifiers

NCT03770533
IDEAL pilot

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

MR-proADM guided
Other group
Treatment:
Other: MR-proADM guided
Standard Care
No Intervention group

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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