NCT06539884

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

August 2, 2024

Last Update Submit

October 1, 2025

Conditions

Keywords

Phoenix Score2005 SIRS (systemic inflammatory response syndrome)PRISM III (Pediatric Mortality Risk Score)PELOD II (Pediatric Logistic Organ Dysfunction)pSOFA (Pediatric sequential organ failure assessment)

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    1,5 year

  • 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.

    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.

    1,5 years

  • +1 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 1 month to 18 years with clinically suspected sepsis will be included in the study.

You may qualify if:

  • Patients aged between 1 month to 18 years.
  • Patients shall be suspected with sepsis clinically.

You may not qualify if:

  • Patients under 1 month of age.
  • Patients over 18 years of age.
  • Patients have not diagnostics of sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akdeniz University

Antalya, Antalya, Turkey (Türkiye)

Location

Akdeniz University

Konyaalti, Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SepsisSystemic Inflammatory Response Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

September 3, 2024

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations