- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241365
The Predictive Role of C-reactive Protein to Albumin Ratio (CAR) in the Treatment of Septic Arthritis in Young Chlidren
Purpose: C-reactive protein to albumin ratio (CAR) has emerged as a novel marker of inflammation. However, almost no research has evaluated the role of CAR in septic arthritis (SA). There is currently controversy over the timing of surgery. Our aim is to explore the application of the CAR in predicting the treatment choice for SA in children under 4 years of age.
Methods: Retrospective analysis of the clinical data from children under four years of age admitted to the Department of Orthopedics at Children's Hospital of Soochow University between January 2016 and December 2022 due to SA. Patients were divided into surgery group and conservative group based on whether the patients underwent surgery. The clinical data of the two groups were compared. Multivariate logistic regression analysis was performed to determine the independent predictors for SA requiring surgical intervention. Receiver operating characteristic (ROC) curves were plotted for the independent predictive indicators, and the area under curve (AUC) was determined. The cut-off value was determined using Youden index, and diagnostic accuracy indicators such as sensitivity (SEN), specificity (SPE), positive predictive value (PPV) and negative predictive value (NPV) were calculated.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- (1) Meeting the aforementioned SA diagnostic criteria, regardless of the affected joint; (2) Completing routine blood and biochemical tests within 24 hours of admission; (3) No surgery or antibiotics administered prior to admission.
Exclusion Criteria:
- (1) Cases of transient synovitis, rheumatism-related diseases (JIA, etc.), simple acute hematogenous osteomyelitis, or acute exacerbation of chronic hematogenous osteomyelitis after revision of the diagnosis; (2) Postoperative iatrogenic infection; (3) Incomplete clinical data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
surgery group
Patients were divided into surgery group and conservative group based on whether the patients underwent surgery.
|
|
conservative group
Patients were divided into surgery group and conservative group based on whether the patients underwent surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CAR
Time Frame: December 2022
|
CAR is an independent predictor indicator for surgery and has good predictive accuracy in chlidren under four years of age with SA.
|
December 2022
|
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021KS024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.
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