Soluble Urokinase Plasminogen Activation ReceptorGRADIENTNCT05580016
Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.
An observational study of Soluble Urokinase Plasminogen Activation Receptor and Abdominal Pain, run by Poitiers University Hospital at 1 site in France.
Trial summary
Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection. Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soluble Urokinase Plasminogen Activation Receptor, Abdominal Pain, Emergency Department
- What is being tested?
- Soluble Urokinase Plasminogen Activation Receptor measurement
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 27 Dec 2023
- 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: Patients admitted to the emergency department for abdominal pain
Who may be able to join
- Patients :
- Over 18 years of age
- Presenting to the ED with abdominal pain for over an hour
- Classified as category 2 or above on the CIMU or FRENCH severity scale
- Necessitating bloodwork at the discretion of the consulting physician
- Who gave his Non-opposition after clear and fair information on the study
Who cannot join
- Patients :
- With pain evocative of kidney stones
- With a chronic inflammatory disease: HIV infection, inflammatory bowel disease, rheumatoid arthritis, cancer
- Chronic renal disease
- Under hospice care
- Intubated
Show all 11Show fewer
- Unstable hemodynamically
- Transferred from a secondary care facility and having undergone previous bloodwork
- Patient unable to understand the information and to give his non-objection
- under guardianship, curatorship or subordination;
- benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in an establishment health or social, adults under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection.
Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection.
Read more
Large randomized controlled trials have been conducted on patients admitted to the emergency department (ER), regardless of the reason for admittance.
These studies have stratified risk based on three cutoffs at initial measurement:
- Low risk : < 3 ng/mL
- Intermediate risk : entre 3 et 6 ng/mL
- High risk : > 6 ng/mL Low levels of SUPAR are associated with low risk of mortality in the short and long term in patients presenting to the ED, no matter the reason for admittance. Risk stratification could be an added decision-making tool for clinicians to comfort hospital discharge.
To the best of our knowledge, there is no available data on the added value of SUPAR for predicting mortality in abdominal sepsis and abdominal pain.
Abdominal pain is responsible for 10 to 30 % of ER admissions. Consequently, abdominal pain is then responsible for roughly 10 % of admissions into medical and surgical wards. Mortality varies depending on patient factors. Mortality is usually stratified on age. In patients under 50 years of age, it is near 8%, but it reaches 19 % in patients over 50.
Diagnostic accuracy also decreases drastically with age, reaching approximately 30 % patients over 75.
Taking this into account, integrating a measure of SUPAR levels into the current standard of care could stratify the risk of complications in patients admitted to the ER with abdominal pain.
- Conditions
- Soluble Urokinase Plasminogen Activation Receptor, Abdominal Pain, Emergency Department, Mortality
- Being tested
- Soluble Urokinase Plasminogen Activation Receptor measurement
- Medical subject headings
- Abdominal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Urokinase Plasminogen Activation Receptor measurementDiagnostic test
In addition to the standard of care, Soluble Urokinase Plasminogen Activation Receptor levels will be measured in patients.
| Study group | Role | What they receive |
|---|---|---|
| Soluble Urokinase Plasminogen Activation Receptor measurement | Not described Receives: Diagnostic Test: Soluble Urokinase Plasminogen Activation Receptor measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of medical and surgical complications within 7 days
7 -day complications as a composite outcome of either:
- Necessity of surgical intervention
- Hospitalisation lasting over 24 hours
- Death in direct relation to the reason for admittance
- Hospital readmission for abdominal pain in a similar abdominal quadrant
Measured: 7 days
Secondary outcomes (3)
Occurrence of medical and surgical complications within 30 days
30 -day complications as a composite outcome of either:
- Necessity of surgical intervention
- Hospitalisation lasting over 24 hours
- Death in direct relation to the reason for admittance
- Hospital readmission for abdominal pain in a similar abdominal quadrant
Measured: 30 days
Optimal cutoff
Determining optimal cutoffs for Soluble Urokinase Plasminogen Activation Receptor through Area Under Curve using Receiver Operating Characteristic method for patients presenting complications of abdominal pain in the first seven days.
Measured: 7 days
Comparison with routine biomarkers
Comparison of diagnostic performance with other routine biomarkers:
Procalcitonine C-Reactive Protein Lactate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start9 Jan 2023
- Primary completion27 Nov 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soluble Urokinase Plasminogen Activation ReceptorStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580016
- Sponsor's protocol ID
- GRADIENT
- Acronym
- GRADIENT
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.
- ClinicalTrials.gov ID
- NCT05580016
- Acronym / sponsor ID
- GRADIENT / GRADIENT
- Conditions
- Soluble Urokinase Plasminogen Activation Receptor, Abdominal Pain, Emergency Department, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 14 Oct 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.
Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection.
Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection.
Large randomized controlled trials have been conducted on patients admitted to the emergency department (ER), regardless of the reason for admittance.
These studies have stratified risk based on three cutoffs at initial measurement:
- Low risk : < 3 ng/mL
- Intermediate risk : entre 3 et 6 ng/mL
- High risk : > 6 ng/mL Low levels of SUPAR are associated with low risk of mortality in the short and long term in patients presenting to the ED, no matter the reason for admittance. Risk stratification could be an added decision-making tool for clinicians to comfort hospital discharge.
To the best of our knowledge, there is no available data on the added value of SUPAR for predicting mortality in abdominal sepsis and abdominal pain.
Abdominal pain is responsible for 10 to 30 % of ER admissions. Consequently, abdominal pain is then responsible for roughly 10 % of admissions into medical and surgical wards. Mortality varies depending on patient factors. Mortality is usually stratified on age. In patients under 50 years of age, it is near 8%, but it reaches 19 % in patients over 50.
Diagnostic accuracy also decreases drastically with age, reaching approximately 30 % patients over 75.
Taking this into account, integrating a measure of SUPAR levels into the current standard of care could stratify the risk of complications in patients admitted to the ER with abdominal pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soluble Urokinase Plasminogen Activation Receptor measurement | – | Diagnostic Test: Soluble Urokinase Plasminogen Activation Receptor measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency department for abdominal pain
Key inclusion criteria (6 listed)
- Over 18 years of age
- Presenting to the ED with abdominal pain for over an hour
- Classified as category 2 or above on the CIMU or FRENCH severity scale
- Necessitating bloodwork at the discretion of the consulting physician
- Who gave his Non-opposition after clear and fair information on the study
Key exclusion criteria (11 listed)
- With pain evocative of kidney stones
- With a chronic inflammatory disease: HIV infection, inflammatory bowel disease, rheumatoid arthritis, cancer
- Chronic renal disease
- Under hospice care
- Intubated
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 |
|---|---|---|
| Soluble Urokinase Plasminogen Activation Receptor measurementIn addition to the standard of care, Soluble Urokinase Plasminogen Activation Receptor levels will be measured in patients. | Diagnostic test | Soluble Urokinase Plasminogen Activation Receptor measurement |
Primary outcome
Occurrence of medical and surgical complications within 7 days
Time frame: 7 days
7 -day complications as a composite outcome of either: * Necessity of surgical intervention * Hospitalisation lasting over 24 hours * Death in direct relation to the reason for admittance * Hospital readmission for abdominal pain in a similar abdominal quadrant
3 secondary outcomes
Occurrence of medical and surgical complications within 30 days
Time frame: 30 days
Optimal cutoff
Time frame: 7 days
Comparison with routine biomarkers
Time frame: 30 days
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 11 Jan 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Soluble Urokinase Plasminogen Activation Receptor and Abdominal Pain, run by Poitiers University Hospital 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 6 inclusion and 11 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 11 Jan 2024. 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?
Occurrence of medical and surgical complications within 7 days (time frame: 7 days). 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 11 Jan 2024.