PSP as Indicator for Urinary Sepsis in ICU

Not yet recruiting

• Conditions: Urinary; Sepsis
• Interventions: Diagnostic Test: pancreatic stone protein "PSP" measurement

• Registration Number: NCT06090526
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-23
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Study Start: 2024-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	pancreatic stone protein "PSP" measurement	Second group (control group) will include 40 nonhospitalized, healthy age and sex matched adults.
cases group	pancreatic stone protein "PSP" measurement	. first group (case group) will include 40 patients who will be suspected to have urinary septicemia at intensive care units of Ain Shams university.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 ICU	value of serial serum PSP levels from admission in ICU to predict infection severity and complications.