Urinary; SepsisNCT06090526
PSP as Indicator for Urinary Sepsis in ICU
An observational study of Urinary; Sepsis, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary; Sepsis
- What is being tested?
- pancreatic stone protein "PSP" measurement
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who was admitted in intensive care units in Ain Shams University and had risk factors for urosepsis.
Who may be able to join
- Adult ill patients at the ICU aged more than 18 years old who at risk of urosepsis.
- Both males and females.
Who cannot join
- - 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.
About this study
Official title: 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
- Conditions
- Urinary; Sepsis
- Being tested
- pancreatic stone protein "PSP" measurement
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic stone protein "PSP" measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: pancreatic stone protein "PSP" measurement | |
| control group | Second group (control group) will include 40 nonhospitalized, healthy age and sex matched adults. Receives: Diagnostic Test: pancreatic stone protein "PSP" measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSP ability to detect urinary sepsis
time course of PSP serum levels above normal range 20-50ng/ml in absence or presence of infection.
Measured: 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.
value of serial serum PSP levels from admission in ICU to predict infection severity and complications.
Measured: measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary; SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Maamoun Ibraheem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090526
- Sponsor's protocol ID
- biomarkes in sepsis
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Stone Protein as Indicator for Urinary Sepsis in Intensive Care Units
- ClinicalTrials.gov ID
- NCT06090526
- Acronym / sponsor ID
- biomarkes in sepsis
- Conditions
- Urinary; Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Diagnostic Test: 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. |
| control group | – | Diagnostic Test: pancreatic stone protein "PSP" measurementSecond group (control group) will include 40 nonhospitalized, healthy age and sex matched adults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who was admitted in intensive care units in Ain Shams University and had risk factors for urosepsis.
Key inclusion criteria (2 listed)
- Adult ill patients at the ICU aged more than 18 years old who at risk of urosepsis.
- Both males and females.
Key exclusion criteria (6 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatic stone protein "PSP" measurementBlood 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. | Diagnostic test | cases group, control group |
Primary outcome
PSP ability to detect urinary sepsis
Time frame: 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.
1 secondary outcome
PSP ability to predict prognosis of sepsis in ICU.
Time frame: measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary; Sepsis, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSP ability to detect urinary sepsis (time frame: measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.