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

Emergencies Clinical Trial

— SuPAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214534
• Other study ID #: RNI 2021 MOUSTAFA
• Secondary ID: 2021-A01930-41
• Status: Completed
• Start date: January 10, 2022
• Est. completion date: April 18, 2022

Study information

• Verified date: November 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between blood supar levels and patient outcome at discharge	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	When the excepted 150 patients will be included, estimated 6 months
Secondary	National Early Warning Score 2 (NEWS2)	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	Hour 0
Secondary	Modified Early Warning Score (MEWS)	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	Hour 0
Secondary	Blood supar levels	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	When the excepted 150 patients will be included, estimated 6 months
Secondary	Blood CRP value	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	Hour 0
Secondary	Cardiac frequency	cardiac frequency will be evaluated when the patient arrives in the emergency service as part of the classical management	Hour 0
Secondary	Respiratory rate	respiratory rate will be evaluated when the patient arrives in the emergency service as part of the classical management	Hour 0
Secondary	Temperature	the temperature will be evaluated when the patient arrives in the emergency service as part of the classical management	Hour 0
Secondary	Systolic blood pressure	systolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management	Hour 0
Secondary	Diastolic blood pressure	diastolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management	Hour 0
Secondary	French triage	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	Hour 0
Secondary	Main diagnosis retained by the physician	Main diagnosis retained	at the end of hospitalization