EmergenciesSuPARNCT05214534
Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies
An observational study of Emergencies and Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Disease, In-hospital Observation
- What is being tested?
- blood supar measurement
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2022to 18 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients requiring clinical observation for a final referral decision and meeting the eligibility criteria will be offered the study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Emergencies, Disease, In-hospital Observation
- Being tested
- blood supar measurement
- Keywords
- Supar, Patient triage, Emergency
- Medical subject headings
- Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood supar measurementOther
The supar values will be measured afterwards on the tube bottoms of the patients included in the study from their usual collection
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Retrospective analysis of the correlation between SuPAR measurement and patient outcome after hospitalization Receives: Other: blood supar measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When the excepted 150 patients will be included, estimated 6 months
Secondary outcomes (11)
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
Measured: Hour 0
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
Measured: Hour 0
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
Measured: When the excepted 150 patients will be included, estimated 6 months
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
Measured: Hour 0
Cardiac frequency
cardiac frequency will be evaluated when the patient arrives in the emergency service as part of the classical management
Measured: Hour 0
Respiratory rate
respiratory rate will be evaluated when the patient arrives in the emergency service as part of the classical management
Measured: Hour 0
Temperature
the temperature will be evaluated when the patient arrives in the emergency service as part of the classical management
Measured: Hour 0
Systolic blood pressure
systolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
Measured: Hour 0
Diastolic blood pressure
diastolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
Measured: Hour 0
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
Measured: Hour 0
Main diagnosis retained by the physician
Main diagnosis retained
Measured: at the end of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 Jan 2022
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farès Moustafa, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214534
- Sponsor's protocol ID
- RNI 2021 MOUSTAFA
- Other IDs
- 2021-A01930-41
- Acronym
- SuPAR
- Status last verified
- Nov 2021
- First submitted
- 8 Dec 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies
- ClinicalTrials.gov ID
- NCT05214534
- Acronym / sponsor ID
- SuPAR / RNI 2021 MOUSTAFA
- Conditions
- Emergencies, Disease, In-hospital Observation
- Keywords
- Supar, Patient triage, Emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: blood supar measurementRetrospective analysis of the correlation between SuPAR measurement and patient outcome after hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients requiring clinical observation for a final referral decision and meeting the eligibility criteria will be offered the study
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Patient under guardianship or curatorship
- Pregnant and breast feeding woman
- Patient admitted for psychiatric pathology
- Patient with a limitation of therapeutics
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood supar measurementThe supar values will be measured afterwards on the tube bottoms of the patients included in the study from their usual collection | Other | Experimental |
Primary outcome
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
11 secondary outcomes
National Early Warning Score 2 (NEWS2)
Time frame: Hour 0
Modified Early Warning Score (MEWS)
Time frame: Hour 0
Blood supar levels
Time frame: When the excepted 150 patients will be included, estimated 6 months
Blood CRP value
Time frame: Hour 0
Cardiac frequency
Time frame: Hour 0
Respiratory rate
Time frame: Hour 0
Temperature
Time frame: Hour 0
Systolic blood pressure
Time frame: Hour 0
Diastolic blood pressure
Time frame: Hour 0
French triage
Time frame: Hour 0
Main diagnosis retained by the physician
Time frame: at the end of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farès Moustafa principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between blood supar levels and patient outcome at discharge (time frame: When the excepted 150 patients will be included, estimated 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.