Hydrocortisone Use During Peri-operation for Pituitary Adenomas

Not Applicable

• Conditions: Adrenal Insufficiency; Surgery; Pituitary Adenoma
• Interventions: Drug: Normal saline; Drug: Hydrocortisone

• Registration Number: NCT04621565
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.

Detailed Description

Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved.

Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed.

For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe.

Study Timeline

• Study First Submitted: 2020-10-28
• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-09
• Last Update Posted: 2020-11-09
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• Patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact
• Patients of either gender aged from 18 years to 70 years

Exclusion Criteria

• Patients with Cushing's disease
• Patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery
• Patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery
• The postoperative pathology result indicates that the tumor is not a pituitary adenoma
• Patients that refuse to participate in the study or those who ask to quit after enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone withholding group	Normal saline	Patients receive no hydrocortisone
Hydrocortisone group	Hydrocortisone	Patients receive routine hydrocortisone

Primary Outcome Measures

Name	Time	Method
Rate of newly-onset adrenal insufficiency	During the first 3 postoperative days	Adrenal insufficiency: lower-than-normal serum cortisol level at 8 a.m., plus the following related symptoms, including serious fatigue, muscle weakness, decreased appetite, nausea, vomiting, diarrhea, low blood pressure, palpitation, and fever.

Secondary Outcome Measures

Name	Time	Method
Rate of newly-onset adrenal insufficiency	From the 3rd postoperative day to the 3rd postoperative month	Adrenal insufficiency: lower-than-normal serum cortisol level at 8 a.m., plus the following related symptoms, including serious fatigue, muscle weakness, decreased appetite, nausea, vomiting, diarrhea, low blood pressure, palpitation, and fever.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China