Clinical trial NCT05580016: Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soluble Urokinase Plasminogen Activation Receptor
Abdominal Pain
Emergency Department
Mortality
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency department for abdominal pain

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Occurrence of medical and surgical complications within 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Occurrence of medical and surgical complications within 30 days
timeFrame: 30 days
measure: Optimal cutoff
timeFrame: 7 days
measure: Comparison with routine biomarkers
timeFrame: 30 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU of Poitiers
Study officials:
References: