- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539884
Does the Phoenix Pediatric Sepsis Prognosis Prediction Scale Work
The aim of this study to understand the compatibility of Phoenix Score, International 2005 SIRS criterias and PRISM III, PELOD scoring systems. Defining pediatric sepsis in our research, epidemiology, scoring systems and prognosis. In addition, we will evaluate the advantages and disadvantages of the Phoenix criteria and assess the compatibility in pediatric sepsis scoring systems. The subject of our research is the use of the Phoenix criteria for pediatric sepsis. The aim of this study was to evaluate whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power. The study is a 1-year prospective observational study. Patients will not undergo any interventional procedure or blood tests due to this study. No intervention will be made in the treatment protocol.
In this study, Akdeniz University medical patients admitted to the Faculty of Pediatric Emergency Department with clinical sepsis suspicion will be included in the study. In 2024 it was aimed to evaluate whether the Phoenix criteria, which are recommended to be used to evaluate the prognosis of sepsis in pediatric patients, are compatible with the 2005 SIRS sepsis diagnosis and grading criteria, pSOFA, PRISM III and PELOD scores, which were widely used for this purpose in previous years and described in detail in the introduction section, and to compare their predictive power in terms of morbidity and mortality.
Study Overview
Detailed Description
Pediatric sepsis is a serious clinical syndrome leading to organ dysfunction develops in children due to infection. Various scoring systems are used to diagnose, treat and asses for pediatric sepsis. The most common of these Pediatric Risk of Mortality Score III (PRISM III) and Pediatric Logistic Organ Dysfunction (PELOD) scores. PRISM III is a set of 17 physiologic scores measured within the first 24 hours of ICU admission that predicts mortality risk based on the variable. In addition PELOD measures morbidity by assessing dysfunction in six organ systems. These scores are important in the management of pediatric sepsis.
tools, but they also have some limitations. For example, the PRISM III score, does not take into the reason for the admission, underlying disease, infectious agent and response to treatment of the patient. PELOD score does not reflect the duration and severity of organ dysfunction. Therefore, new studies and improvements in the definition of pediatric sepsis and scores are in progress. Pediatric SOFA (pSOFA) score is another option for definition and to approach the pediatric sepsis. It is used to assess the severity of sepsis and organ function in children. These criteria include respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. For each system, specific parameters are considered and scored. These scores are summed to calculate the SOFA score and the risk of organ failure is estimated. The Pediatric Functional Status Scale (FSS) is a rapid, objective and reliable tool used to assess the functional status of children during hospitalization. FSS, mental status, sensory function, communication, motor function, nutrition and respiratory status and each area is given a score between 1 (normal) and 5 (very severe dysfunction). Total scores range from 6 to 30. In recent years, a new set of criteria called the Phoenix criteria a definition of pediatric sepsis has been proposed. Phoenix criterias which includes both systemic inflammatory response syndrome (SIRS) and organ dysfunction criterias aims more accurate and early recognition of pediatric sepsis. Whether the Phoenix criteria are compatible with PRISM III and PELOD scores has not yet been investigated. The aim of this study to understand the compatibility of Phoenix Score, International 2005 SIRS criterias and PRISM III, PELOD scoring systems. Defining pediatric sepsis in our research, epidemiology, scoring systems and prognosis. In addition, we will evaluate the advantages and disadvantages of the Phoenix criteria and assess the compatibility in pediatric sepsis scoring systems. The subject of our research is the use of the Phoenix criteria for pediatric sepsis. The aim of this study was to evaluate whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power. The study is a 1-year prospective observational study. Patients will not undergo any interventional procedure or blood tests due to this study. No intervention will be made in the treatment protocol.
In this study, Akdeniz University medical patients admitted to the Faculty of Pediatric Emergency Department with clinical sepsis suspicion will be included in the study. In 2024 it was aimed to evaluate whether the Phoenix criteria, which are recommended to be used to evaluate the prognosis of sepsis in pediatric patients, are compatible with the 2005 SIRS sepsis diagnosis and grading criteria, pSOFA, PRISM III and PELOD scores, which were widely used for this purpose in previous years and described in detail in the introduction section, and to compare their predictive power in terms of morbidity and mortality.
Patient/Volunteer/Participant definition and number: The patient group consisted of patients admitted to the Pediatric Emergency Department of Akdeniz University Faculty of Medicine who were clinically suspected of sepsis or admitted to the general pediatric service or pediatric intensive care unit with suspected sepsis. The study is a one-year prospective observational study. The number of patients will be determined by the number of patients admitted during this period and the group of patients with suspected sepsis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Antalya
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Antalya, Antalya, Turkey (Türkiye)
- Akdeniz University
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Konyaalti, Antalya, Turkey (Türkiye), 07100
- Akdeniz University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Patients aged between 1 month to 18 years.
- Patients shall be suspected with sepsis clinically.
Exclusion criteria:
- Patients under 1 month of age.
- Patients over 18 years of age.
- Patients have not diagnostics of sepsis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phoenix sepsis score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
Time Frame: 1.5 year
|
Phoenix sepsis score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
|
1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SOFA score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
Time Frame: 1,5 year
|
SOFA score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
|
1,5 year
|
|
Phoenix sepsis score, SOFA score, and 2005 SIRS -sepsis definition define all children with sepsis.
Time Frame: 1,5 years
|
Phoenix sepsis score, SOFA score, and 2005 SIRS -sepsis definition define all children with sepsis.
|
1,5 years
|
|
Phoenix sepsis score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
Time Frame: 1,5 years
|
Phoenix sepsis score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
|
1,5 years
|
|
SOFA score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
Time Frame: 1,5 years
|
SOFA score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
|
1,5 years
|
|
Phoenix sepsis score correlates with FSS calculated at discharge.
Time Frame: 1,5 years
|
Phoenix sepsis score correlates with FSS calculated at discharge.
|
1,5 years
|
|
SOFA score correlates with FSS calculated at discharge.
Time Frame: 1,5 years
|
SOFA score correlates with FSS calculated at discharge.
|
1,5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBAEK-391
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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