PSP as Indicator for Urinary Sepsis in ICU

NCT06090526 | Unknown

• 1 other identifier: biomarkes in sepsis
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urinary; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

control group

Second group (control group) will include 40 nonhospitalized, healthy age and sex matched adults.

Diagnostic Test: pancreatic stone protein "PSP" measurement

Interventions

pancreatic stone protein "PSP" measurement DIAGNOSTIC_TEST

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.

cases group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Complete blood count. 2. Liver and kidney functions. 3. Serum electrolytes (Na and k). 4. C-reactive protein(CRP) 5. Procalcitonin. 6. PSP

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 19, 2023
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share