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

NCT05580016 | Completed

• 1 other identifier: GRADIENT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Soluble Urokinase Plasminogen Activation Receptor; Abdominal Pain; Emergency Department; Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Occurrence of medical and surgical complications within 30 days

  30 days

• Optimal cutoff

  7 days

• Comparison with routine biomarkers

  30 days

Study Arms (1)

Soluble Urokinase Plasminogen Activation Receptor measurement

Diagnostic Test: Soluble Urokinase Plasminogen Activation Receptor measurement

Interventions

Soluble Urokinase Plasminogen Activation Receptor measurement DIAGNOSTIC_TEST

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

Soluble Urokinase Plasminogen Activation Receptor measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the emergency department for abdominal pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU of Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Abdominal Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: January 9, 2023
• Primary Completion: November 27, 2023
• Study Completion: December 27, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

FR (1)