Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 11:47 PM
Study NCT ID:
NCT01247961
Status:
WITHDRAWN
Last Update Posted:
2016-12-12
First Post:
2010-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Treatment With Dexamethasone in Mild Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018038', 'term': 'dexamethasone acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-08', 'studyFirstSubmitDate': '2010-11-19', 'studyFirstSubmitQcDate': '2010-11-23', 'lastUpdatePostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Inflammation (measured by c-reactive protein level)', 'timeFrame': '48 hours', 'description': 'C-reactive protein (CRP) is a well-established inflammatory prognostic marker in acute pancreatitis. Primary comparison will be between median CRP levels at 48 hours between treatment arms.'}], 'secondaryOutcomes': [{'measure': 'Safety parameters', 'timeFrame': '72 hours post-randomization', 'description': 'We will monitor for incidence of malignant hyperglycemia (blood sugar\\>400 mg/dL), psychosis or culture-documented infectious complications.'}, {'measure': 'Composite clinical outcome', 'timeFrame': 'Up to 14 days from hospital admission', 'description': 'A composite clinical endpoint including development of either 1) pancreatic necrosis, 2) persistent organ dysfunction defined according to Atlanta symposium criteria 3) requirement for treatment in an intensive care unit and/or 4) development of culture-documented infection will be used to evaluate impact of treatment with dexamethasone on clinical outcomes in the study population.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients With Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'This pilot trial will evaluate the following in patients with acute pancreatitis:\n\n1. Safety profile of early treatment with intravenous dexamethasone\n2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis\n3. Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>=18 years\n* Diagnosis of acute pancreatitis confirmed by at least 2 of the following:\n\n 1. Typical epigastric abdominal pain\n 2. Elevation amylase/lipase \\>3 times upper limit normal and/or\n 3. Confirmatory findings on cross-sectional imaging\n* Enrollment within 8 hours of presentation\n\nExclusion Criteria:\n\n* Class II or greater NYHA heart failure\n* Oxygen dependent COPD\n* Chronic kidney disease\\>stage 2\n* Cirrhosis\n* Existing necrosis on abdominal CT\n* Organ dysfunction prior to enrollment\n* Sepsis\n* Acute respiratory distress syndrome\n* Malignancy not in remission for at least 5 years\n* Active drug use\n* Known allergy to dexamethasone\n* Altered mental status\n* Insulin-requiring diabetes\n* Abdominal surgery within 60 days'}, 'identificationModule': {'nctId': 'NCT01247961', 'briefTitle': 'Early Treatment With Dexamethasone in Mild Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '2010P-002192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg intravenous dexamethasone', 'description': 'Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.', 'interventionNames': ['Drug: Dexamethasone acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Equal volume of normal saline administered as a single intravenous dose at enrollment.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dexamethasone acetate', 'type': 'DRUG', 'description': '10 mg intravenous given as single administration with optional repeat dose after 36 hours.', 'armGroupLabels': ['10 mg intravenous dexamethasone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bechien U Wu, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Center for Pancreatic Disease, Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, Center for Pancreatic Disease', 'investigatorFullName': 'Bechien Wu, MD, MPH', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}