PSP as Indicator for Urinary Sepsis in ICU

NCT ID: NCT06090526

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-03-31

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

Detailed Description

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Conditions

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Urinary; Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

pancreatic stone protein "PSP" measurement

Intervention Type 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.

control group

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

pancreatic stone protein "PSP" measurement

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Maamoun Ibraheem

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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biomarkes in sepsis

Identifier Type: -

Identifier Source: org_study_id

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