PSP as Indicator for Urinary Sepsis in ICU

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06090526
Collaborator
(none)
80
11

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: pancreatic stone protein "PSP" measurement

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Pancreatic Stone Protein as Indicator for Urinary Sepsis in Intensive Care Units
Anticipated Study Start Date :
May 1, 2024
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Sayed Maamoun Ibraheem, Doctor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT06090526
Other Study ID Numbers:
  • biomarkes in sepsis
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023