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PSP as Indicator for Urinary Sepsis in ICU

Pancreatic Stone Protein as Indicator for Urinary Sepsis in Intensive Care Units

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06090526
Enrollment
80
Registered
2023-10-19
Start date
2024-05-01
Completion date
2025-03-31
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary; Sepsis

Brief summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. pancreatic stone protein has been studied as biomarker of sepsis and results suggests that it has higher diagnostic performance. The main objective of this study is to identify ability of pancreatic stone protein (PSP) as a new biomarker for diagnosis of urosepsis in Intensive Care Units comparison to other biomarkers and its role as a prognostic marker for mortality

Interventions

DIAGNOSTIC_TESTpancreatic stone protein PSP measurement

Blood samples will be collected for biomarker (PCT, CRP, and PSP) measurements in admission and 24 hours, 72 hours from admission and patients will be followed until death or discharge from the ICU or for 30 days, whichever occurred.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult ill patients at the ICU aged more than 18 years old who at risk of urosepsis. * Both males and females.

Exclusion criteria

* \- Age less than 18 years. * Patients with a clinical diagnosis of sepsis at admission. * Critically ill septic patients with a diagnosis other than urosepsis. * Critically ill patients who were diagnosed to have urosepsis outside Ain Shams university intensive care and transferred to it. * Malignant tumor patients. * Uremic patients undergoing dialysis.

Design outcomes

Primary

MeasureTime frameDescription
PSP ability to detect urinary sepsismeasurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICUtime course of PSP serum levels above normal range 20-50ng/ml in absence or presence of infection.

Secondary

MeasureTime frameDescription
PSP ability to predict prognosis of sepsis in ICU.measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICUvalue of serial serum PSP levels from admission in ICU to predict infection severity and complications.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026