Hydrocortisone Use During Peri-operation for Pituitary Adenomas

November 3, 2020 updated by: Peking Union Medical College Hospital

Withholding Hydrocortisone vs Routine Use of Hydrocortisone During Peri-operation in Pituitary Adenoma Patients With Intact Hypothalamus-Pituitary-Adrenal Axis: Randomized Controlled Trial to Assess Safety and Complications

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrocortisone withholding group
Patients receive no hydrocortisone
Drug: Normal saline
No hydrocortisone or other steroids are given before, during, and after the surgery, except that patients develop postoperative adrenal insufficiency. If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program.
Other Names:
  • Intravenous normal saline
Active Comparator: Hydrocortisone group
Patients receive routine hydrocortisone
Drug: Hydrocortisone
Hydrocortisone sodium succinate is given on the operation day (100mg at 0800 & 100mg at 2000), the postoperative day 1 (100mg at 0800 & 50mg at 2000), and the postoperative day 2 (25mg at 0800). Hydrocortisone (po.) is then given starting from the afternoon of postoperative day 2 (20mg at 1600 and 0800) to the end of the first postoperative week, and 20mg at 0800 during the second postoperative week. This is called the "hydrocortisone taper program". If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program.
Other Names:
  • Hydrocortisone sodium succinate (iv.) & Hydrocortisone (po.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of newly-onset adrenal insufficiency
Time Frame: 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.
During the first 3 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of newly-onset adrenal insufficiency
Time Frame: 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.
From the 3rd postoperative day to the 3rd postoperative month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of newly-developed diabetes mellitus
Time Frame: During the first 3 postoperative months
A random reading of blood sugar level more than 200 mg/dL (11.1 mmol/L), or a reading after two hours (after OGTT) over 200 mg/dL (11.1 mmol/L) indicates diabetes mellitus.
During the first 3 postoperative months
Rate of newly-developed diabetes insipidus
Time Frame: During the first 3 postoperative months
Urine volume > 300ml for more than 3h or > 6 liter per day, specific gravity of urine <1.003, and serum sodium levels > 145 mmol/L indicate diabetes insipidus.
During the first 3 postoperative months
Concentration of blood electrolytes
Time Frame: At the 3rd postoperative month
The level of Na+, K+, and Ca++ in the blood
At the 3rd postoperative month
Concentration of blood cells
Time Frame: At the 3rd postoperative month
Numbers of erythrocytes, leukocytes, neutrophils, lymphocytes, thrombocytes in the blood
At the 3rd postoperative month
Percentage of blood cells
Time Frame: At the 3rd postoperative month
Percentage of neutrophils, monocytes, lymphocytes of the leukocytes
At the 3rd postoperative month
Concentration of indexes of coagulation function #1
Time Frame: At the 3rd postoperative month
Prothrombin time, activated partial thromboplastin time, and thrombin time
At the 3rd postoperative month
Level of international normalized ratio
Time Frame: At the 3rd postoperative month
Level of international normalized ratio
At the 3rd postoperative month
Level of D-Dimer
Time Frame: At the 3rd postoperative month
Level of D-Dimer
At the 3rd postoperative month
Rate of deep venous thrombosis
Time Frame: During the first 3 postoperative months
Deep venous thrombosis as detected by ultrasound
During the first 3 postoperative months
Rate of other complications
Time Frame: During the first 3 postoperative months
Decreased bone density, osteoporosis, fracture, acne, and infections.
During the first 3 postoperative months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Bing Xing, MD, Neurosurgery, Peking Union Medical College Hospital, Beijing, China
  • Study Director: Wei Lian, MD, Neurosurgery, Peking Union Medical College Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-2608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual participant data will be available upon reasonable requests to the study chair, Dr. Bing Xing, or the study director, Dr. Wei Lian.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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