Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-27 @ 11:10 AM
Study NCT ID:
NCT01770457
Status:
UNKNOWN
Last Update Posted:
2013-07-25
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytokine Response in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples will be collected at specific time points. Initial time point determined by start of Vasopressors Then sequential serum samples will be drawn from patients to examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine response in septic shock', 'timeFrame': 'Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7', 'description': 'his study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.\n\nThe specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU population'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease.\n\nThe specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).', 'detailedDescription': 'Patients must be on vasopressors Patients cannot be on pressors for \\> 24 hrs prior to consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with septic shock admitted to intensive care units who are receiving vasopressors for septic shock for \\<24 hrs. No significant exclusions exist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ICU patients: . 18 years admitted with septic shock\n* Receiving Vasopressors \\< 24 hrs\n\nExclusion Criteria:\n\n* Consent refused by patient or SDM\n* Received Vasopressors \\> 24hrs'}, 'identificationModule': {'nctId': 'NCT01770457', 'briefTitle': 'Cytokine Response in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Cytokine Response in Septic Shock', 'orgStudyIdInfo': {'id': 'B2009:130'}}, 'contactsLocationsModule': {'locations': [{'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Wendy Janz, RN', 'role': 'CONTACT', 'email': 'wjanz@hsc.mb.ca', 'phone': '204-787-1405'}, {'name': 'Anand Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Health Sciences Centre, Winnipeg', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Anand Kumar, MD', 'role': 'CONTACT', 'email': 'akumar61@yahoo.com', 'phone': '204-291-0372'}, {'name': 'Wendy Janz, RN', 'role': 'CONTACT', 'email': 'wjanz@hsc.mb.ca', 'phone': '204-787-1405'}], 'overallOfficials': [{'name': 'Anand Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician/ investigator WRHA', 'investigatorFullName': 'Dr. Anand Kumar', 'investigatorAffiliation': 'University of Manitoba'}}}}