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NCT05580016: GRADIENT
Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.
trial testing Soluble Urokinase Plasminogen Activation Receptor measurement in Soluble Urokinase Plasminogen Activation Receptor in 200 participants. Completed in 27 December 2023.
27 November 2023
Quick facts
| Lead sponsor | Poitiers University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 9 January 2023 |
| Primary completion | 27 November 2023 |
| Estimated completion | 27 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Soluble Urokinase Plasminogen Activation Receptor measurement
Conditions studied
- Soluble Urokinase Plasminogen Activation Receptor — all drugs for Soluble Urokinase Plasminogen Activation Receptor →
- Abdominal Pain — all drugs for Abdominal Pain →
- Emergency Department — all drugs for Emergency Department →
- Mortality — all drugs for Mortality →
Sponsor
Poitiers University Hospital
Who can join
18 and older, any sex, with Soluble Urokinase Plasminogen Activation Receptor or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05580016
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05580016 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poitiers University Hospital
- Last refreshed: 11 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05580016.
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