Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-04 @ 3:56 AM
Study NCT ID:
NCT02936232
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2016-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Sepsis and Septic Shock Registry
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': 'ESTIMATED', 'count': 3000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2016-10-09', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28-day', 'description': 'According to hospital discharge record review and telephone follow-up.'}], 'secondaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': '90-day', 'description': 'According to hospital discharge record review and telephone follow-up.'}, {'measure': 'Organ support treatment (mechanical ventilation)', 'timeFrame': 'hospital discharge (non-survivors) or 90 days (survivors)', 'description': 'According to hospital record review'}, {'measure': 'Organ support treatment (renal replacement therapy)', 'timeFrame': 'hospital discharge (non-survivors) or 90 days (survivors)', 'description': 'According to hospital record review'}, {'measure': 'ICU length of stay', 'timeFrame': 'hospital discharge (non-survivors) or 90 days (survivors)', 'description': 'According to hospital record review'}, {'measure': 'Hospital length of stay', 'timeFrame': 'hospital discharge (non-survivors) or 90 days (survivors)', 'description': 'According to hospital record review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.', 'detailedDescription': 'This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments.\n\nRegistered data can be used for quality control and clinical research to reduce sepsis-related mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe sepsis or septic shock', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* two of more systemic inflammatory reaction syndrome criteria fever \\> 38.3 'C or hypothermia \\< 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL)\n* suspected or proven infection\n* any organ dysfunction as follows:\n\n 1. cardiovascular (hypotension, systolic blood pressure \\<90 mmHg, mean arterial pressure \\<70mmHg)\n 2. tissue hypoperfusion (lactate above upper limits laboratory normal)\n 3. acute lung injury (PaO2/inspired oxygen fraction \\< 250 in the absence of pneumonia, PaO2/inspired oxygen fraction \\< 200 in the presence of pneumonia)\n 4. acute kidney injury (Urine output \\< 0.5mL/kg/hr for at least 2 hrs Serum creatinine \\> 2.0 mg/dL)\n 5. acute liver injury (Total bilirubin \\> 2mg/dL)\n 6. acute coagulopathy (Platelet count \\< 100,000/μL or prothrombin time, international normalized ratio \\> 1.5)\n\nExclusion Criteria:\n\n* age less than 18 years old\n* patients with cardiac arrest at presentation\n* patients with advanced directives not to deliver aggressive organ supportive management"}, 'identificationModule': {'nctId': 'NCT02936232', 'briefTitle': 'Severe Sepsis and Septic Shock Registry', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Severe Sepsis and Septic Shock Registry', 'orgStudyIdInfo': {'id': '1408-003-599'}}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'You Hwan Jo, MD, PhD', 'role': 'CONTACT', 'email': 'drakejo@snubh.org', 'phone': '(82)-31-787-7574'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '110714', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung Su Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kanesu@gmail.com', 'phone': '82-10-8033-1127'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-707', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Huijai Lee, MD', 'role': 'CONTACT', 'email': 'emdrlee@gmail.com', 'phone': '82-2-870-2664'}], 'facility': 'Seoul Metropolitan Government-Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyung Su Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kanesu@gmail.com', 'phone': '82-10-8033-1127'}, {'name': 'Woon Wong Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'kwy711@hanmail.net', 'phone': '82-2-2072-4751'}], 'overallOfficials': [{'name': 'Gil Joon Suh, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Inje University Ilsan Paik Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}, {'name': 'Chosun University Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, {'name': 'Hanyang University Seoul Hospital', 'class': 'OTHER'}, {'name': "Bucheon St. Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gil Joon Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}