SepsisNCT06539884
Does the Phoenix Pediatric Sepsis Prognosis Prediction Scale Work
An observational study of Sepsis and Sepsis, Severe, run by Oguz Dursun at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Sepsis, Sepsis, Severe
- What is being tested?
- Observational
- How many people
- 25 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Sep 2024to 1 Oct 2025
- How long will I take part?
- 1 Year
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients aged 1 month to 18 years with clinically suspected sepsis will be included in the study.
Who may be able to join
- Patients aged between 1 month to 18 years.
- Patients shall be suspected with sepsis clinically.
Who cannot join
- Patients under 1 month of age.
- Patients over 18 years of age.
- Patients have not diagnostics of sepsis
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Akdeniz University
Antalya, Antalya
Akdeniz University
Konyaalti, Antalya, 07100
About this study
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.
Read the 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.
- Conditions
- Sepsis, Sepsis, Severe
- Being tested
- Observational
- Keywords
- Phoenix Score, 2005 SIRS (systemic inflammatory response syndrome), PRISM III (Pediatric Mortality Risk Score), PELOD II (Pediatric Logistic Organ Dysfunction), pSOFA (Pediatric sequential organ failure assessment)
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Evaluating whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phoenix sepsis score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
Phoenix sepsis score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
Measured: 1.5 year
Secondary outcomes (6)
SOFA score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
SOFA score correlates with length of stay in pediatric intensive care unit, length of stay in hospital, and mortality.
Measured: 1,5 year
Phoenix sepsis score, SOFA score, and 2005 SIRS -sepsis definition define all children with sepsis.
Phoenix sepsis score, SOFA score, and 2005 SIRS -sepsis definition define all children with sepsis.
Measured: 1,5 years
Phoenix sepsis score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
Phoenix sepsis score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
Measured: 1,5 years
SOFA score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
SOFA score correlates with PRISM III, PELOD II scores, and the highest VIS observed during hospitalization.
Measured: 1,5 years
Phoenix sepsis score correlates with FSS calculated at discharge.
Phoenix sepsis score correlates with FSS calculated at discharge.
Measured: 1,5 years
SOFA score correlates with FSS calculated at discharge.
SOFA score correlates with FSS calculated at discharge.
Measured: 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start3 Sep 2024
- Primary completion1 Aug 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oguz Dursun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oguz Dursun, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539884
- Sponsor's protocol ID
- TBAEK-391
- Status last verified
- Oct 2025
- First submitted
- 2 Aug 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Phoenix Pediatric Sepsis Prognosis Prediction Scale Work
- ClinicalTrials.gov ID
- NCT06539884
- Acronym / sponsor ID
- TBAEK-391
- Conditions
- Sepsis, Sepsis, Severe
- Keywords
- Phoenix Score, 2005 SIRS (systemic inflammatory response syndrome), PRISM III (Pediatric Mortality Risk Score), PELOD II (Pediatric Logistic Organ Dysfunction), pSOFA (Pediatric sequential organ failure assessment)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oguz DursunUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 6 Aug 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients aged 1 month to 18 years with clinically suspected sepsis will be included in the study.
Key inclusion criteria (2 listed)
- Patients aged between 1 month to 18 years.
- Patients shall be suspected with sepsis clinically.
Key exclusion criteria (3 listed)
- Patients under 1 month of age.
- Patients over 18 years of age.
- Patients have not diagnostics of sepsis
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 |
|---|---|---|
| ObservationalEvaluating whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power. | Other | – |
Primary outcome
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.
6 secondary outcomes
SOFA 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, SOFA score, and 2005 SIRS -sepsis definition define all children with sepsis.
Time frame: 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
SOFA 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 FSS calculated at discharge.
Time frame: 1,5 years
SOFA score correlates with FSS calculated at discharge.
Time frame: 1,5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis, Severe, run by Oguz Dursun at 2 sites in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 2 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.