PSP as Indicator for Urinary Sepsis in ICU

Study Overview
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Brief Summary
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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

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

Conditions
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Urinary; Sepsis

Intervention / Treatment
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* Diagnostic Test: pancreatic stone protein PSP measurement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases group<br>. first group (case group) will include 40 patients who will be suspected to have urinary septicemia at intensive care units of Ain Shams university. | Diagnostic Test: pancreatic stone protein PSP measurement<br>* 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.<br>|
| control group<br>Second group (control group) will include 40 nonhospitalized, healthy age and sex matched adults. | Diagnostic Test: pancreatic stone protein PSP measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSP ability to detect urinary sepsis | time course of PSP serum levels above normal range 20-50ng/ml in absence or presence of infection. | measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSP ability to predict prognosis of sepsis in ICU. | value of serial serum PSP levels from admission in ICU to predict infection severity and complications. | measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU |