Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline plasma cortisol level
研究概览
简要总结
The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18
- •Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)
排除标准
- •Patients with pre-existing hyperthyroidism or Cushing's syndrome
- •Patients with long-term glucocorticoids replacement history
- •Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)
- •Patients with severe panhypopituitarism
- •Patients with history of radiotherapy of the pituitary gland
研究组 & 干预措施
D. Impaired function, high-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.
干预措施: Prednisone (Drug)
D. Impaired function, high-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.
干预措施: Hydrocortisone (Drug)
B. Normal function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
干预措施: Hydrocortisone (Drug)
B. Normal function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
干预措施: Prednisone (Drug)
C. Impaired function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
干预措施: Hydrocortisone (Drug)
C. Impaired function, low-dose GC
Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;
干预措施: Prednisone (Drug)
结局指标
主要结局
Change from baseline plasma cortisol level
时间窗: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Plasma cortisol at 8:00, 16:00, 24:00 respectively
Change from baseline 24-hour urine free cortisol
时间窗: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
24-hour urine free cortisol
Change from baseline insulin tolerance test result
时间窗: 7, 30, 90 days post-op
insulin tolerance test result
Change from baseline plasma ACTH level
时间窗: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
ACTH at 8:00;
次要结局
- Change from baseline plasma free T3 level(1, 3, 5, 7, 30, 90, 180, 360 days post-op)
- Number of patients with postoperative infection(For the duration of hospital stay, an expected average of 7 days)
- Change from baseline health-related quality of life(7, 30, 90 days post-op)
- Number of patients with recurred tumor(3,6,12 months after surgery)
- Sodium, potassium concentration in the blood and urine(Daily post-op,for the duration of hospital stay, an expected average of 7 days)
- Change from baseline plasma TSH level(1, 3, 5, 7, 30, 90, 180, 360 days post-op)
- Change from baseline plasma free T4 level(1, 3, 5, 7, 30, 90, 180, 360 days post-op)
- Urine output(Daily post-op,for the duration of hospital stay, an expected average of 7 days)
研究者
Shu Jiang
Professor Shu Jiang
West China Hospital