Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-24 @ 4:15 PM
Study NCT ID:
NCT02084134
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2014-03-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peri-Operative Steroid Management in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsilverstein@wustl.edu', 'phone': '314-747-7006', 'title': 'Dr. Julie Silverstein', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Steroid Treatment Arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg\n\nhydrocortisone: 100mg at the time of surgery\n\ndexamethasone: 0.5mg every 6 hours for a total of four doses', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-steroid Treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death', 'notes': 'One patient in non-steroid group died from meningitis which was not felt to be related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adrenal Insufficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid Treatment Arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg\n\nhydrocortisone: 100mg at the time of surgery\n\ndexamethasone: 0.5mg every 6 hours for a total of four doses'}, {'id': 'OG001', 'title': 'Non-steroid Treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks following surgery', 'description': 'Adrenal insufficiency was defined by a 30 or 60 min cortisol \\< 18 during a cosyntropin stimulation test', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Discharged on Glucocorticoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid Treatment Arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg\n\nhydrocortisone: 100mg at the time of surgery\n\ndexamethasone: 0.5mg every 6 hours for a total of four doses'}, {'id': 'OG001', 'title': 'Non-steroid Treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day (Day of hospital discharge)', 'description': 'Patient charts were reviewed to identify patients who were discharged on prednisone', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steroid Treatment Arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg\n\nhydrocortisone: 100mg at the time of surgery\n\ndexamethasone: 0.5mg every 6 hours for a total of four doses'}, {'id': 'FG001', 'title': 'Non-steroid Treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Steroid Treatment Arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg\n\nhydrocortisone: 100mg at the time of surgery\n\ndexamethasone: 0.5mg every 6 hours for a total of four doses'}, {'id': 'BG001', 'title': 'Non-steroid Treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2014-03-05', 'resultsFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2014-03-10', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-31', 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adrenal Insufficiency', 'timeFrame': '6 weeks following surgery', 'description': 'Adrenal insufficiency was defined by a 30 or 60 min cortisol \\< 18 during a cosyntropin stimulation test'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Discharged on Glucocorticoids', 'timeFrame': '1 day (Day of hospital discharge)', 'description': 'Patient charts were reviewed to identify patients who were discharged on prednisone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pituitary adenoma', 'Pituitary Tumor', 'transsphenoidal resection', 'pituitary cyst'], 'conditions': ['Pituitary Adenoma', 'Pituitary Diseases']}, 'referencesModule': {'references': [{'pmid': '15163331', 'type': 'BACKGROUND', 'citation': "Agha A, Liew A, Finucane F, Baker L, O'Kelly P, Tormey W, Thompson CJ. Conventional glucocorticoid replacement overtreats adult hypopituitary patients with partial ACTH deficiency. Clin Endocrinol (Oxf). 2004 Jun;60(6):688-93. doi: 10.1111/j.1365-2265.2004.02035.x."}, {'pmid': '20339931', 'type': 'BACKGROUND', 'citation': 'Marko NF, Hamrahian AH, Weil RJ. Immediate postoperative cortisol levels accurately predict postoperative hypothalamic-pituitary-adrenal axis function after transsphenoidal surgery for pituitary tumors. Pituitary. 2010 Sep;13(3):249-55. doi: 10.1007/s11102-010-0227-6.'}, {'pmid': '19326985', 'type': 'BACKGROUND', 'citation': 'Marko NF, Gonugunta VA, Hamrahian AH, Usmani A, Mayberg MR, Weil RJ. Use of morning serum cortisol level after transsphenoidal resection of pituitary adenoma to predict the need for long-term glucocorticoid supplementation. J Neurosurg. 2009 Sep;111(3):540-4. doi: 10.3171/2008.12.JNS081265.'}, {'pmid': '3372683', 'type': 'BACKGROUND', 'citation': 'Hout WM, Arafah BM, Salazar R, Selman W. Evaluation of the hypothalamic-pituitary-adrenal axis immediately after pituitary adenomectomy: is perioperative steroid therapy necessary? J Clin Endocrinol Metab. 1988 Jun;66(6):1208-12. doi: 10.1210/jcem-66-6-1208.'}, {'pmid': '19052341', 'type': 'BACKGROUND', 'citation': 'Bhansali A, Dutta P, Bhat MH, Mukherjee KK, Rajput R, Bhadada S. Rational use of glucocorticoid during pituitary surgery--a pilot study. Indian J Med Res. 2008 Sep;128(3):294-9.'}, {'pmid': '12050244', 'type': 'BACKGROUND', 'citation': 'Inder WJ, Hunt PJ. Glucocorticoid replacement in pituitary surgery: guidelines for perioperative assessment and management. J Clin Endocrinol Metab. 2002 Jun;87(6):2745-50. doi: 10.1210/jcem.87.6.8547.'}], 'seeAlsoLinks': [{'url': 'https://vfh.wustl.edu/', 'label': 'Washington University School of Medicine, Research Participant Registry'}]}, 'descriptionModule': {'briefSummary': 'During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.\n\nSurgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches.\n\nObjectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes', 'detailedDescription': 'Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection.\n\nExclusion Criteria:\n\n* Patients with Cushing's Disease (pituitary tumor which secretes ACTH)\n* Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism)\n* Patients on long term glucocorticoid therapy\n* Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery"}, 'identificationModule': {'nctId': 'NCT02084134', 'acronym': 'Steroid', 'briefTitle': 'Peri-Operative Steroid Management in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts', 'orgStudyIdInfo': {'id': '201110174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'steroid treatment arm', 'description': 'Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg', 'interventionNames': ['Drug: hydrocortisone', 'Drug: dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'non-steroid treatment', 'description': 'Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).'}], 'interventions': [{'name': 'hydrocortisone', 'type': 'DRUG', 'otherNames': ['intravenous hydrocortisone'], 'description': '100mg at the time of surgery', 'armGroupLabels': ['steroid treatment arm']}, {'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['intravenous dexamethasone'], 'description': '0.5mg every 6 hours for a total of four doses', 'armGroupLabels': ['steroid treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Julie M. Silverstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}