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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
Sponsor:
Collaborators:
Technische Universitaet Braunschweig
Helmholtz Centre for Infection Research
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:

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

Detailed Description:
Clinical decision-support systems (CDSS) are designed to solve knowledge-intensive tasks for supporting decision-making processes. Although many approaches for designing CDSS have been proposed, due to high implementation costs, as well as the lack of interoperability features, current solutions are not wellestablished across different institutions. Recently, the use of standardized formalisms for knowledge representation as terminologies as well as the integration of semantically enriched clinical information models, as openEHR Archetypes, and their reuse within CDSS are theoretically considered as key factors for reusable CDSS. The investigators already successfully transferred their concept into a prototype and evaluated the practicability on clinical data sets and in close cooperation between the clinicians and the technical experts. To the author's knowledge, currently, there are no openEHR based CDSS approaches which have been implemented and evaluated with such complex and important clinical contexts. Hence, the first clinically evaluated CDSS based on openEHR was successfully designed. When enhancing the described approach and implementing a live system, it might support clinicians to identify the patient's course of disease at an early stage, which can lead to better outcome for the patient. Furthermore, the system can serve as a basis for integrating (cross-institutional) machine learning components that could facilitate dealing with other high-complex decision problems or revealing yet unknown disease patterns.

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Study Type : Observational
Actual Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PICU-Patients
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pediatric patients from newborn to young adults up to 18 years that are admitted to our PICU, there is a wide range from infectious causes, post-operative-care of pediatric surgery, cardiac surgery, organ-transplants etc, newborns connatal syndromes and organdysplasia.
Criteria

Inclusion Criteria:

  • all pediatric patients admitted to our PICU

Exclusion Criteria:

  • patients that are supposed to stay for less than 12 hours on our PICU

Information from the National Library of Medicine

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


Locations
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Germany
Hannover Medical School
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Technische Universitaet Braunschweig
Helmholtz Centre for Infection Research
Investigators
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Study Chair: Michael Marschollek, PhD Hannover Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03661450    
Other Study ID Numbers: 7804_BO_S_2018
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannover Medical School:
Clinical Decision-Support System
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes