Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Overview
- Phase
- Phase 4
- Intervention
- Prednisone
- Conditions
- Pituitary Neoplasms
- Sponsor
- West China Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change from baseline plasma cortisol level
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Shu Jiang
Professor Shu Jiang
West China Hospital
Eligibility Criteria
Inclusion Criteria
- •Age \>= 18
- •Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Prednisone
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.
Intervention: Hydrocortisone
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;
Intervention: Hydrocortisone
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;
Intervention: Prednisone
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;
Intervention: Hydrocortisone
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;
Intervention: Prednisone
Outcomes
Primary Outcomes
Change from baseline plasma cortisol level
Time Frame: 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
Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
24-hour urine free cortisol
Change from baseline insulin tolerance test result
Time Frame: 7, 30, 90 days post-op
insulin tolerance test result
Change from baseline plasma ACTH level
Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
ACTH at 8:00;
Secondary Outcomes
- 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)