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Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies (SuPAR)

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ClinicalTrials.gov Identifier: NCT05214534
Recruitment Status : Completed
First Posted : January 28, 2022
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
In this study, the investigators will investigate the relationship between the blood level of SuPAR at admission to the emergency department of the Clermont-Ferrand University Hospital, and the outcome of patients after their hospitalization in a short stay unit.

Condition or disease Intervention/treatment
Emergencies Disease In-hospital Observation Other: blood supar measurement

Detailed Description:

SuPAR (Soluble urokinase Plasminogen Activator Receptor) is a non-specific prognostic blood biomarker related to inflammation. An elevated SuPAR value reflects significant chronic inflammation and predicts a risk of negative outcome and even short-term mortality (intra-hospital, 30 days, 90 days). Conversely, a low SuPAR value is a strong indicator of good prognosis and low risk of readmission. It is therefore of interest to know a patient's SuPAR blood level to enable the clinician to decide whether the patient should be admitted or discharged. SuPAR has been shown to be the best prognostic marker associated with the presence and progression of disease and risk of mortality. The use of SuPAR in clinical routine adds significant complementary information to the standard Early Warning Score assessment and to the classical parameters such as CRP, PCT, Lactate, ALT, Bilirubin, and CBC in the pre-admission of acute patients.

Patients admitted to the emergency department will receive their usual management. We will test the added value of the SuPAR assay in the prognosis of patients' outcome at discharge.

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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies
Actual Study Start Date : January 10, 2022
Actual Primary Completion Date : April 18, 2022
Actual Study Completion Date : April 18, 2022

Group/Cohort Intervention/treatment
Experimental
Retrospective analysis of the correlation between SuPAR measurement and patient outcome after hospitalization
Other: blood supar measurement
The supar values will be measured afterwards on the tube bottoms of the patients included in the study from their usual collection




Primary Outcome Measures :
  1. Relationship between blood supar levels and patient outcome at discharge [ Time Frame: When the excepted 150 patients will be included, estimated 6 months ]
    Relation between blood supar levels measured and patient outcome at discharge evaluated as : return home = good evolution; hospitalization = bad evolution; admission to an intensive care unit or death = unfavorable evolution


Secondary Outcome Measures :
  1. National Early Warning Score 2 (NEWS2) [ Time Frame: Hour 0 ]
    Score allowing the classification of the urgency of a patient. The minimum value is 0 and the maximum value is 20. Higher scores mean a worse outcome

  2. Modified Early Warning Score (MEWS) [ Time Frame: Hour 0 ]
    Score allowing the classification of the urgency of a patient. The minimum value is 0 and the maximum value is 17. Higher scores mean a worse outcome

  3. Blood supar levels [ Time Frame: When the excepted 150 patients will be included, estimated 6 months ]
    the supar values are classifies into three categories : < 3 ng/ml : supports the referral decision. the patient's general condition is good and the prognosis is high 3-6 ng/ml : presence of pathologies and comorbidity factors. readmissions and high mortality beyond 6 months >6 ng/ml : requires special clinical attention, high risk of mortality

  4. Blood CRP value [ Time Frame: Hour 0 ]
    the CRP value will be assessed during the blood test performed as part of the classical management when the patient arrives in the emergency room

  5. Cardiac frequency [ Time Frame: Hour 0 ]
    cardiac frequency will be evaluated when the patient arrives in the emergency service as part of the classical management

  6. Respiratory rate [ Time Frame: Hour 0 ]
    respiratory rate will be evaluated when the patient arrives in the emergency service as part of the classical management

  7. Temperature [ Time Frame: Hour 0 ]
    the temperature will be evaluated when the patient arrives in the emergency service as part of the classical management

  8. Systolic blood pressure [ Time Frame: Hour 0 ]
    systolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management

  9. Diastolic blood pressure [ Time Frame: Hour 0 ]
    diastolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management

  10. French triage [ Time Frame: Hour 0 ]
    French Emergency Nurses Classification in Hospitals (FRENCH) ranks priorities from 5 to 1 (from least urgent to most urgent) according to prognosis and complexity/severity of the medical condition

  11. Main diagnosis retained by the physician [ Time Frame: at the end of hospitalization ]
    Main diagnosis retained


Biospecimen Retention:   Samples Without DNA
bottoms of the of blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all patients requiring clinical observation for a final referral decision and meeting the eligibility criteria will be offered the study
Criteria

Inclusion Criteria:

  • Patient, male or female, over 18 years old
  • Admitted to the emergency department of the Clermont-Ferrand University Hospital for a medical reason,
  • Classified as FRENCH II or III by the nurse organizer of the reception management
  • Necessity of clinical observation in the Short Term Hospitalization Unit for final orientation decision
  • Requires a blood test upon arrival in the emergency department
  • Able to give informed non-opposition to participate in the research.
  • Affiliation to a Social Security system

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Pregnant and breast feeding woman
  • Patient admitted for psychiatric pathology
  • Patient with a limitation of therapeutics
  • Refusal to participate
  • Patient hospitalized because of a particular social context

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214534


Locations
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France
CHU clermont-ferrand
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Farès Moustafa University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT05214534    
Other Study ID Numbers: RNI 2021 MOUSTAFA
2021-A01930-41 ( Other Identifier: 2021-A01930-41 )
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Supar
Patient triage
Emergency
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes