Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients (CADDIE2)
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|ClinicalTrials.gov Identifier: NCT03661450|
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : August 14, 2019
This trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Two experienced paediatric intensivists, who are blinded for the CDSS results, will analyse the electronic patient file (EPF) for SIRS criteria and thus establish our Goldstandard. All SIRS events recognized by the CDSS during the patient's stay are taken into account and will be compared with the established Goldstandard.
The secondary goal of this trial is to evaluate the CDSS-results with the assessment of SIRS by paediatric doctors during their routine work on the PICU.
|Condition or disease||Intervention/treatment|
|SIRS Sepsis Pediatric SIRS||Diagnostic Test: Clinical Decision-Support System|
|Study Type :||Observational|
|Actual Enrollment :||177 participants|
|Official Title:||Evaluation of the Accuracy of a Clinical Decision-Support System (CDSS) to Support Detection of SIRS and Sepsis in Paediatric Intensive Care Patients Compared to Medical Specialists|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||March 31, 2019|
|Actual Study Completion Date :||March 31, 2019|
Pediatric patients admitted after 01.08.2018
Diagnostic Test: Clinical Decision-Support System
Patient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity
- Sensitivity and specificity of CDSS compared to Goldstandard [ Time Frame: 8 months ]Assessment of sensitivity and specificity of a CDSS compared to Goldstandard established by two independed blinded paediatric intensivists, the analysis will be done with Wald-Confidence interval and comparison of the lower limit of the confidence interval with the defined range of the null hypothesis.
- Sensitivity and specificity of CDSS on daily level [ Time Frame: 8 months ]Evaluation of sensitivity and specificity of the CDSS on daily levels compared with the Goldstandard with respect to correlation of days within one patient's course with general estimating equations.
- Comparison of CDSS with assessment of MDs taking care of the patients [ Time Frame: 10 months ]Evaluation of sensitivity and specificity of the CDSS on daily level and patient level compared with recognition of SIRS by paediatric doctors during daily routine with McNemar testing and general estimating equations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661450
|Hannover Medical School|
|Hannover, Lower Saxony, Germany, 30625|
|Study Chair:||Michael Marschollek, PhD||Hannover Medical School|