Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
Study NCT ID:
NCT02188992
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2014-07-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples of serum and plasma will be stored frozen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of septic shock', 'timeFrame': 'Within first 72 hours'}, {'measure': 'Confirmation of suspected infection', 'timeFrame': 'within first 72 hours'}], 'secondaryOutcomes': [{'measure': 'Hospital outcome (lived/died)', 'timeFrame': 'Within first 72 hours'}, {'measure': 'Time to septic shock onset', 'timeFrame': 'Within the first 72 hours'}, {'measure': 'Death from sepsis', 'timeFrame': 'Within first 72 hours'}, {'measure': 'Organ dysfunction, total and individual organs as determined by SOFA score', 'timeFrame': 'within first 72 hours'}, {'measure': 'subsequent admission to critical care', 'timeFrame': 'within first 72 hours'}, {'measure': 'Changes in immune activation in those patients who develop any of the events mention in previous outcomes (i.e. septic shock, death, organ dysfunction, admission to critical care)', 'timeFrame': 'within first 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Immune activation', 'Systemic Inflammation', 'Emergency Medicine', 'Critical Care'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '30291379', 'type': 'DERIVED', 'citation': 'Shankar-Hari M, Datta D, Wilson J, Assi V, Stephen J, Weir CJ, Rennie J, Antonelli J, Bateman A, Felton JM, Warner N, Judge K, Keenan J, Wang A, Burpee T, Brown AK, Lewis SM, Mare T, Roy AI, Wright J, Hulme G, Dimmick I, Gray A, Rossi AG, Simpson AJ, Conway Morris A, Walsh TS. Early PREdiction of sepsis using leukocyte surface biomarkers: the ExPRES-sepsis cohort study. Intensive Care Med. 2018 Nov;44(11):1836-1848. doi: 10.1007/s00134-018-5389-0. Epub 2018 Oct 5.'}, {'pmid': '27481622', 'type': 'DERIVED', 'citation': 'Datta D, Conway Morris A, Antonelli J, Warner N, Brown KA, Wright J, Simpson AJ, Rennie J, Hulme G, Lewis SM, Mare TA, Cookson S, Weir CJ, Dimmick I, Keenan J, Rossi AG, Shankar-Hari M, Walsh TS; ExPRES Sepsis Investigators. Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers. BMJ Open. 2016 Aug 1;6(8):e011335. doi: 10.1136/bmjopen-2016-011335.'}]}, 'descriptionModule': {'briefSummary': "Between 6 and 16% of patients presenting to hospital emergency departments have infections, with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue is that, at time of presentation, it can be difficult to determine who has inflammation as a result of infection and who does not.\n\nSome of the patients with infections will deteriorate to organ failure ('severe sepsis') including failure of the heart and blood vessels to maintain normal blood pressure ('septic shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with a significant mortality, which can be reduced by early intervention. However identifying those patients who are at high risk of deteriorating to septic shock can be difficult on initial presentation to hospital, and thus these patients risk being 'triaged' to an inappropriate level of care and/or missing the crucial early interventions which can modify mortality. Equally failure to identify which patients have underlying infections can lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are often unable to accurately identify those patients with infection, and those who are likely to deteriorate to severe sepsis and septic shock.\n\nInvestigators in this group have recently identified several signatures of immune system activation which predict those patients who are likely to deteriorate, and which patients with suspected infection subsequently have this confirmed. Such tests would have major benefits for the management of patients with early suspected infection and sepsis if they can be translated into a test usable in everyday clinical practice. This study aims to determine the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and their predictive ability for developing established septic shock. From this investigators aim to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test.\n\nStudy hypothesis is:\n\nMeasurement of markers of immune activation will allow i) Risk stratification for deterioration into severe sepsis ii) Risk stratification for death amongst patients presenting with sepsis iii) Identification of patients with confirmed sepsis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the initial 12 hours following presentation to hospital with suspected sepsis, i.e. patients with signs of systemic inflammation (i.e. meeting criteria for SIRS) where the treating clinician takes microbial samples and/or starts empiric antibiotics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>16 (\\>18 in England)\n* SIRS criteria met (2 or more of White Cell Count (WCC) \\>11 or \\<4, Heart Rate (HR) \\>90, Respiratory Rate (RR) \\>20 or temp \\>38 or \\<36oC)\n* Clinical suspicion of sepsis (cultures taken or antibiotics started)\n* Enrolled within 12 hours of hospital admission\n\nExclusion Criteria:\n\n* Acute pancreatitis\n* Septic shock at time of enrolment\n* Severe organ failure at time of enrolment (immediate requirement for ventilation, vasopressor or renal replacement therapy)\n* Haematological malignancy\n* Recent chemotherapy (past 2 weeks)\n* Myelodysplastic syndromes\n* Known neutropaenia\n* HIV infection\n* Pregnancy\n* Blood transfusion \\>4 units in past week\n* Oral Corticosteroids for \\>24 hours prior to enrolment\n* Decision not for active therapy/ palliative care at admission\n* Lacking in capacity to consent and nearest relative/welfare guardian not available for consultation and proxy consent (Scotland only)'}, 'identificationModule': {'nctId': 'NCT02188992', 'acronym': 'ExPRES', 'briefTitle': 'Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Early Prediction of Severe Sepsis (ExPRESSepsis) Study', 'orgStudyIdInfo': {'id': '2013/0267'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients with sepsis syndrome, without criteria for severe sepsis/septic shock. These patients are recruited from the emergency department.'}, {'label': 'Cohort 2', 'description': 'Patients with community acquired sepsis syndrome REQUIRING critical care admission due to severity of sepsis. These patients are recruited from the critical care areas (ICU/HDU).'}, {'label': 'Cohort 3', 'description': 'Patients without sepsis syndrome. Age and gender matched to cohort 1, and recruited from Emergency Department.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE1 4LP', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Tim S Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lothian/University of Edinburgh'}, {'name': 'John Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle-upon-Tyne Hospitals NHS Trust'}, {'name': 'Manu Shankar-Hari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}, {'name': 'Andrew Conway Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'John Simpson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle University'}, {'name': 'Alasdair Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lothian/University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technology Strategy Board, United Kingdom', 'class': 'OTHER'}, {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}