Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.

Abdominal Pain Clinical Trial

— GRADIENT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580016
• Other study ID #: GRADIENT
• Status: Completed
• Start date: January 9, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Abdominal Pain
• Emergencies
• Emergency Department
• Mortality

Intervention

Diagnostic Test:
• Soluble Urokinase Plasminogen Activation Receptor measurement
In addition to the standard of care, Soluble Urokinase Plasminogen Activation Receptor levels will be measured in patients.

Locations

Country	Name	City	State
France	CHU of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Secondary	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	30 days
Secondary	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.	7 days
Secondary	Comparison with routine biomarkers	Comparison of diagnostic performance with other routine biomarkers: Procalcitonine C-Reactive Protein Lactate	30 days