Peri-Operative Steroid Management in Patients
关键词
抽象
描述
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.
日期
最后验证: | 02/28/2018 |
首次提交: | 03/04/2014 |
提交的预估入学人数: | 03/09/2014 |
首次发布: | 03/10/2014 |
上次提交的更新: | 03/14/2018 |
最近更新发布: | 04/10/2018 |
首次提交结果的日期: | 01/30/2018 |
首次提交质量检查结果的日期: | 01/30/2018 |
首次发布结果的日期: | 02/28/2018 |
实际学习开始日期: | 02/29/2012 |
预计主要完成日期: | 11/20/2016 |
预计完成日期: | 12/30/2016 |
状况或疾病
干预/治疗
Drug: steroid treatment arm
Drug: steroid treatment arm
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: steroid treatment arm Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg | Drug: steroid treatment arm 100mg at the time of surgery |
No Intervention: non-steroid treatment 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). |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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. Exclusion Criteria: - Patients with Cushing's Disease (pituitary tumor which secretes ACTH) - Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism) - Patients on long term glucocorticoid therapy - Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery |
结果
主要结果指标
1. Number of Participants With Adrenal Insufficiency [6 weeks following surgery]
次要成果指标
1. Percentage of Patients Discharged on Glucocorticoids [1 day (Day of hospital discharge)]