Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-25 @ 6:54 PM
Study NCT ID:
NCT02052895
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2014-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utility of Presepsin in Distinguishing Between Sepsis and SIRS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hnsato@mochida.co.jp', 'phone': '+81-3-3225-6331', 'title': 'Hironori Sato', 'organization': 'Mochida Pharmaceutical'}, 'certainAgreement': {'otherDetails': "The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 50 days from the time submitted to the sponsor for review. Only if the disclosure becomes an obstacle to the sponsor's business or registration or maintenance of the sponsor's invention, the sponsor may require changes to the communication and may extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': "Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.", 'eventGroups': [{'id': 'EG000', 'title': 'Sepsis/SIRS', 'description': 'Patients with sepsis or SIRS', 'otherNumAtRisk': 190, 'otherNumAffected': 0, 'seriousNumAtRisk': 190, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients without SIRS, sepsis, or end stage renal disease', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'End Stage Renal Disease', 'description': 'Patients with end stage renal disease, without SIRS or sepsis', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Gastrointestinal hemmorage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Presepsin', 'description': 'ROC-AUC of presepsin for discriminating between Sepsis and SIRS'}, {'id': 'OG001', 'title': 'Procalcitonin', 'description': 'ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7218', 'groupId': 'OG000', 'lowerLimit': '0.6455', 'upperLimit': '0.7981'}, {'value': '0.6901', 'groupId': 'OG001', 'lowerLimit': '0.6130', 'upperLimit': '0.7672'}]}]}], 'analyses': [{'pValue': '0.3924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of ROC-AUC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0317', 'ciLowerLimit': '-0.0409', 'ciUpperLimit': '0.1043', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 7 days', 'description': 'For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sepsis/SIRS', 'description': 'Patients with sepsis or SIRS'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients without SIRS, sepsis, or end stage renal disease'}, {'id': 'FG002', 'title': 'End Stage Renal Disease', 'description': 'Patients with end stage renal disease, without SIRS or sepsis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sepsis/SIRS', 'description': 'Patients with sepsis or SIRS'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients without SIRS, sepsis, or end stage renal disease'}, {'id': 'BG002', 'title': 'End Stage Renal Disease', 'description': 'Patients with end stage renal disease, without SIRS or sepsis'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.80', 'spread': '15.99', 'groupId': 'BG000'}, {'value': '65.80', 'spread': '13.11', 'groupId': 'BG001'}, {'value': '53.70', 'spread': '19.5', 'groupId': 'BG002'}, {'value': '59.00', 'spread': '16.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Subjects who didn't meet inclusion/exclusion criteria were excluded."}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma Blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2014-01-30', 'resultsFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-04', 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis', 'timeFrame': 'Up to 7 days', 'description': 'For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Presepsin', 'Sepsis', 'SIRS'], 'conditions': ['SIRS', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Sepsis/SIRS Patients\n\nInclusion Criteria:\n\n* Male or female aged ≥ 21 years\n* Appropriate clinical data to enable classification into sepsis or SIRS\n* Written informed consent by the patient or legally authorized representative\n* Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation\n\nExclusion Criteria:\n\n* No informed consent\n* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \\< 20%\n\nControl\n\nInclusion Criteria:\n\n* Male or female aged ≥ 21 years\n* Does not meet clinical criteria for sepsis or SIRS\n* Written informed consent by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* No informed consent\n* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \\< 20%\n\nEnd Stage Renal Disease\n\nInclusion Criteria:\n\n* Male or female aged ≥ 21 years\n* Documented diagnosis of end stage renal disease currently undergoing dialysis\n* Does not meet clinical criteria for sepsis or SIRS\n* Written informed consent by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* No informed consent\n* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \\< 20%'}, 'identificationModule': {'nctId': 'NCT02052895', 'briefTitle': 'Utility of Presepsin in Distinguishing Between Sepsis and SIRS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mochida Pharmaceutical Company, Ltd.'}, 'officialTitle': 'Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'IVD2001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis/SIRS', 'description': 'Patients with sepsis or SIRS'}, {'label': 'Control', 'description': 'Patients without SIRS, sepsis, or end stage renal disease'}, {'label': 'End Stage Renal Disease', 'description': 'Patients with end stage renal disease, without SIRS or sepsis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01805', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Stanley Nasraway, MD, FCCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mochida Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}