Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02190994
Status:
UNKNOWN
Last Update Posted:
2014-07-15
First Post:
2014-07-05
Brief Title:
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None