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临床试验/NCT04621565
NCT04621565Unknown不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Patients receive no hydrocortisone

干预措施: Normal saline (Drug)

Hydrocortisone group

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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