Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-11 @ 3:11 PM
Study NCT ID:
NCT03364920
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'up to 28 days', 'description': 'The level of serum maresin-1 predicts the severity of severe acute pancreatitis'}], 'secondaryOutcomes': [{'measure': 'The incidence of MODS', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The level of serum maresin-1 predicts the severity of severe acute pancreatitis'}, {'measure': 'The incidence of IPN', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The level of serum maresin-1 predicts the severity of severe acute pancreatitis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maresin-1', 'SAP', 'IPN', 'MODS', 'Mortality'], 'conditions': ['Pancreatitis, Acute']}, 'descriptionModule': {'briefSummary': 'This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes severe acute pancreatitis between 18ys and 75ys.Patients with disorder of glucolipide metabolism will be excluded. Alcoholic pancreatitis and HTG-AP patients will be also excluded. Patients will be divided into 2 groups according to their level of serum maresin-1.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Severe Acute Pancreatitis\n* Biliary pancreatitis\n* 7 days of the onset\n\nExclusion Criteria:\n\n* Surgical patients\n* Serious diseases and infection\n* Alcoholic pancreatitis\n* Hypertriglyceridemia pancreatitis\n* Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI\\>30'}, 'identificationModule': {'nctId': 'NCT03364920', 'briefTitle': 'Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'Serum Maresin-1 Level Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis Patients', 'orgStudyIdInfo': {'id': 'SMPSSAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal level of serum maresin-1'}, {'label': 'abnormal level of serum maresin-1'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Weiqin Li', 'role': 'CONTACT', 'email': 'luyingying126@sina.cn', 'phone': '13962531994'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weiqin Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Weiqin Li', 'investigatorAffiliation': 'Nanjing University School of Medicine'}}}}