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

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 Overview

• Status: Completed
• Conditions: Mortality; Abdominal Pain; Emergency Department; Soluble Urokinase Plasminogen Activation Receptor
• Intervention / Treatment: Diagnostic test: Soluble Urokinase Plasminogen Activation Receptor measurement

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Jérémy GUENEZAN, Hospital Practictioner; Phone Number: 0549444444; Email: jeremy.guenezan@chu-poitiers.fr
• Study Contact Backup: Name: Sabrina SEGUIN, CRA; Phone Number: +33 0549443229; Email: sabrina.seguin@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86021
    • CHU of POITIERS
    • Contact: Sabrina SEGUIN, CRA; Phone Number: +33 0549443229; Email: sabrina.seguin@chu-poitiers.fr
    • Contact: Jérémy GUENEZAN, Hospital Practictioner; Phone Number: +33 0549444444; Email: jeremy.guenezan@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the emergency department for abdominal pain

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Soluble Urokinase Plasminogen Activation Receptor measurement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Comparison with routine biomarkers	Comparison of diagnostic performance with other routine biomarkers: Procalcitonine C-Reactive Protein Lactate	30 days

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Signs and Symptoms, Digestive; Emergencies; Abdominal Pain; Abdomen, Acute; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Plasminogen
• Other Study ID Numbers: GRADIENT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No