Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-26 @ 7:51 PM
Study NCT ID:
NCT03661450
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of CDSS compared to Goldstandard', 'timeFrame': '8 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of CDSS on daily level', 'timeFrame': '8 months', 'description': "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."}, {'measure': 'Comparison of CDSS with assessment of MDs taking care of the patients', 'timeFrame': '10 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Decision-Support System'], 'conditions': ['SIRS', 'Sepsis', 'Pediatric SIRS']}, 'referencesModule': {'references': [{'pmid': '33602206', 'type': 'DERIVED', 'citation': 'Wulff A, Montag S, Rubsamen N, Dziuba F, Marschollek M, Beerbaum P, Karch A, Jack T. Clinical evaluation of an interoperable clinical decision-support system for the detection of systemic inflammatory response syndrome in critically ill children. BMC Med Inform Decis Mak. 2021 Feb 18;21(1):62. doi: 10.1186/s12911-021-01428-7.'}, {'pmid': '31221891', 'type': 'DERIVED', 'citation': 'Wulff A, Montag S, Steiner B, Marschollek M, Beerbaum P, Karch A, Jack T. CADDIE2-evaluation of a clinical decision-support system for early detection of systemic inflammatory response syndrome in paediatric intensive care: study protocol for a diagnostic study. BMJ Open. 2019 Jun 19;9(6):e028953. doi: 10.1136/bmjopen-2019-028953.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pediatric patients admitted to our PICU\n\nExclusion Criteria:\n\n* patients that are supposed to stay for less than 12 hours on our PICU'}, 'identificationModule': {'nctId': 'NCT03661450', 'acronym': 'CADDIE2', 'briefTitle': 'Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '7804_BO_S_2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PICU-Patients', 'description': 'Pediatric patients admitted after 01.08.2018', 'interventionNames': ['Diagnostic Test: Clinical Decision-Support System']}], 'interventions': [{'name': 'Clinical Decision-Support System', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity', 'armGroupLabels': ['PICU-Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Michael Marschollek, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technische Universitaet Braunschweig', 'class': 'OTHER'}, {'name': 'Helmholtz Centre for Infection Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}