Withholding Hydrocortisone vs Routine Use of Hydrocortisone During Peri-operation in Pituitary Adenoma Patients With Intact Hypothalamus-Pituitary-Adrenal Axis: Randomized Controlled Trial to Assess Safety and Complications
试验速览
- 阶段
- 不适用
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- Rate of newly-onset adrenal insufficiency
研究概览
简要总结
The investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.
详细描述
Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved.
Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed.
For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, investigator, and outcome assessors are all prevented from having knowledge of the interventions assigned to individual participants. Care provider knows the individualized interventions.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact
- •Patients of either gender aged from 18 years to 70 years
排除标准
- •Patients with Cushing's disease
- •Patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery
- •Patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery
- •The postoperative pathology result indicates that the tumor is not a pituitary adenoma
- •Patients that refuse to participate in the study or those who ask to quit after enrollment
研究组 & 干预措施
Hydrocortisone withholding group
Patients receive no hydrocortisone
干预措施: Normal saline (Drug)
Hydrocortisone group
Patients receive routine hydrocortisone
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Rate of newly-onset adrenal insufficiency
时间窗: During the first 3 postoperative days
Adrenal insufficiency: lower-than-normal serum cortisol level at 8 a.m., plus the following related symptoms, including serious fatigue, muscle weakness, decreased appetite, nausea, vomiting, diarrhea, low blood pressure, palpitation, and fever.
次要结局
- Rate of newly-onset adrenal insufficiency(From the 3rd postoperative day to the 3rd postoperative month)
