PSP as Indicator for Urinary Sepsis in ICU

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary; Sepsis
• Intervention / Treatment: Diagnostic test: pancreatic stone protein "PSP" measurement

• Study Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients who was admitted in intensive care units in Ain Shams University and had risk factors for urosepsis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cases group; . 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; 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.
control group; Second group (control group) will include 40 nonhospitalized, healthy age and sex matched adults.	Diagnostic test: pancreatic 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: biomarkes in sepsis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No