Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions

Phase 4

• Conditions: Pituitary Neoplasms; Craniopharyngiomas
• Interventions: Drug: Hydrocortisone; Drug: Prednisone

• Registration Number: NCT02190994
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-05
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Study First Posted: 2014-07-15
• Last Update Posted: 2014-07-15
• Primary Completion: 2014-08
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B. Normal function, low-dose GC	Hydrocortisone	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;
C. Impaired function, low-dose GC	Hydrocortisone	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;
B. Normal function, low-dose GC	Prednisone	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;
C. Impaired function, low-dose GC	Prednisone	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;
D. Impaired function, high-dose GC	Hydrocortisone	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.
D. Impaired function, high-dose GC	Prednisone	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline plasma cortisol level	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	1, 3, 5, 7, 30, 90, 180, 360 days post-op	24-hour urine free cortisol
Change from baseline insulin tolerance test result	7, 30, 90 days post-op	insulin tolerance test result
Change from baseline plasma ACTH level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	ACTH at 8:00;

Secondary Outcome Measures

Name	Time	Method
Sodium, potassium concentration in the blood and urine	Daily post-op,for the duration of hospital stay, an expected average of 7 days	Concentration of sodium, potassium in the blood and urine
Change from baseline plasma free T3 level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	plasma free T3 level
Number of patients with postoperative infection	For the duration of hospital stay, an expected average of 7 days	Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.
Change from baseline health-related quality of life	7, 30, 90 days post-op	The 15-Dimensions measure of health-related quality of life
Number of patients with recurred tumor	3,6,12 months after surgery	Enhanced MRI scan of the sellar region.
Change from baseline plasma TSH level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	plasma TSH level
Change from baseline plasma free T4 level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	plasma free T4 level
Urine output	Daily post-op,for the duration of hospital stay, an expected average of 7 days	24-hour urine output

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China