Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-01 @ 12:08 AM
Study NCT ID:
NCT00842933
Status:
TERMINATED
Last Update Posted:
2011-06-29
First Post:
2009-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adrenal Insufficiency 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'whyStopped': 'Unable to meet enrollment goal prior to PI transfer', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-28', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure for this study is the number of hours receiving steroid dosing.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.', 'timeFrame': 'up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Septic shock', 'Acute adrenal insufficiency'], 'conditions': ['Septic Shock', 'Acute Adrenal Insufficiency']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP \\> 65 mm Hg off of vasopressors).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 18 years of age or older\n* Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient\n* Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock\n\nExclusion Criteria:\n\n* Patients with documented allergic or anaphylactic reactions to corticosteroids\n* Patients who have received steroid therapy within 6 months of presentation\n* Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone\n* Patients who have received etomidate in the preceding 12 hours\n* Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome).\n* Documented Human Immunodeficiency Virus (HIV) infection\n* Pregnancy\n* Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids\n* Administration of additional medications which may suppress the hypothalamic-pituitary axis:\n\n * Ketoconazole\n * Aminoglutethimide\n * Mitotane\n * Megestrol acetate\n * Suramin'}, 'identificationModule': {'nctId': 'NCT00842933', 'briefTitle': 'Adrenal Insufficiency in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock', 'orgStudyIdInfo': {'id': '0207-0012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.', 'interventionNames': ['Drug: Corticosteroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care group', 'description': 'Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.', 'interventionNames': ['Drug: Corticosteroid']}], 'interventions': [{'name': 'Corticosteroid', 'type': 'DRUG', 'otherNames': ['corticosteroids,prednisone,methylpredisolone,hydrocortisone'], 'description': 'Cessation of corticosteroids 24 hours after cessation of vasopressors', 'armGroupLabels': ['Experimental group']}, {'name': 'Corticosteroid', 'type': 'DRUG', 'otherNames': ['prednisone,methylprednisolone,corticosteroid,hydrocortisone'], 'description': 'Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock', 'armGroupLabels': ['Standard of care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Laura J Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital, Houston, TX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Laura J Moore, MD', 'oldOrganization': 'The Methodist Hospital, Department of Surgery'}}}}