Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-04-16 @ 2:06 PM
Study NCT ID:
NCT02366650
Status:
UNKNOWN
Last Update Posted:
2015-10-21
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Help in the Emergency Room to Detect Organ Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infection-induced organ dysfunction', 'timeFrame': '72 hours', 'description': 'To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department.'}], 'secondaryOutcomes': [{'measure': 'To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers', 'timeFrame': '72 hours'}, {'measure': 'To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.', 'timeFrame': '90 days'}, {'measure': 'To investigate and identify risk factors for a negative long-term (5-10 year) outcome.', 'timeFrame': '10 years'}, {'measure': '• Organ dysfunction 24-36 and 72 hours after arriving at the hospital', 'timeFrame': '72 hrs'}, {'measure': '• Primary diagnosis infection (y/n)', 'timeFrame': '72 hrs'}, {'measure': '• number of days on ward and ICU', 'timeFrame': '90 days'}, {'measure': '• number of days of antibiotics , time to effective antibiotics', 'timeFrame': '72 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni) ≥18 years of age ii) 1 or more of the following criteria: Saturation\\<90% without oxygen or \\<93% with oxygen or reported saturation\\<90%, Respiratory frequency \\>25/min, Altered mental awareness, Heart rate \\>120/min, Systolic blood pressure \\<100 mm Hg. iv) informed consent.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02366650', 'acronym': 'HERO', 'briefTitle': 'Help in the Emergency Room to Detect Organ Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study', 'orgStudyIdInfo': {'id': 'HERO1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lund ED', 'description': 'appr 100-200 patients at Lund ED'}, {'label': 'Helsingborg ED', 'description': 'appr 100-200 patients at Helsingborg ED'}, {'label': 'Vancouver ED', 'description': "appr 100 patients at St Paul's hospital ED"}, {'label': 'Bern ED', 'description': 'appr 100 patients at Bern ED'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'John Boyd', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Helsingborg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jonas Tverring', 'role': 'CONTACT', 'email': 'jonas@tverring.com'}], 'facility': 'Helsingborg', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Adam Linder', 'role': 'CONTACT', 'email': 'adam.linder@med.lu.se'}], 'facility': 'Lund ED', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Bern', 'status': 'COMPLETED', 'country': 'Switzerland', 'facility': 'Bern ED', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Adam Linder', 'investigatorAffiliation': 'Region Skane'}}}}