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

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

Sponsors

Lead Sponsor: West China Hospital

Source 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.

Overall Status Unknown status
Start Date August 2013
Completion Date December 2014
Primary Completion Date August 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline plasma cortisol level 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma ACTH level 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline 24-hour urine free cortisol 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline insulin tolerance test result 7, 30, 90 days post-op
Secondary Outcome
Measure Time Frame
Change from baseline plasma TSH level 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Sodium, potassium concentration in the blood and urine Daily post-op,for the duration of hospital stay, an expected average of 7 days
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
Change from baseline plasma free T3 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
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hydrocortisone

Description: used intravenously

Intervention Type: Drug

Intervention Name: Prednisone

Description: used as tablet form

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Shu Jiang, M.D. Principal Investigator West China Hospital, Sichuan University, Chengdu, Sichuan, PR China
Overall Contact

Last Name: Senlin Yin, M.D.

Phone: +86 13072808795

Email: [email protected]

Location
Facility: Status: Contact: Investigator: West China Hospital, Sichuan University Senlin Yin, M.D. +86 13072808795 [email protected] Shu Jiang, M.D. Principal Investigator Senlin Yin, M.D. Sub-Investigator Peizhi Zhou, M.D. Sub-Investigator
Location Countries

China

Verification Date

July 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: West China Hospital

Investigator Full Name: Shu Jiang

Investigator Title: Professor Shu Jiang

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: A. Normal function, non-GC replacement

Type: No Intervention

Description: No glucocorticoid replacement will be given perioperatively.

Label: B. Normal function, low-dose GC

Type: Active Comparator

Description: 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;

Label: C. Impaired function, low-dose GC

Type: Active Comparator

Description: 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;

Label: D. Impaired function, high-dose GC

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov