Adrenal Insufficiency, Pituitary Adenoma, Surgery
Conditions
Keywords
Pituitary Adenomas, Peri-operation, Hydrocortisone, Adrenal Insufficiency
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.
Interventions
DRUGNormal 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.
DRUGHydrocortisone
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant, investigator, and outcome assessors are all prevented from having knowledge of the interventions assigned to individual participants. Care provider knows the individualized interventions.
Intervention model description
Participants are assigned to one of two groups, whether using hydrocortisone or not during peri-operation, in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentration of blood electrolytes | At the 3rd postoperative month | The level of Na+, K+, and Ca++ in the blood |
| Concentration of blood cells | At the 3rd postoperative month | Numbers of erythrocytes, leukocytes, neutrophils, lymphocytes, thrombocytes in the blood |
| Percentage of blood cells | At the 3rd postoperative month | Percentage of neutrophils, monocytes, lymphocytes of the leukocytes |
| Concentration of indexes of coagulation function #1 | At the 3rd postoperative month | Prothrombin time, activated partial thromboplastin time, and thrombin time |
| Rate of newly-developed diabetes mellitus | 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. |
| Level of D-Dimer | At the 3rd postoperative month | Level of D-Dimer |
| Rate of deep venous thrombosis | During the first 3 postoperative months | Deep venous thrombosis as detected by ultrasound |
| Rate of other complications | During the first 3 postoperative months | Decreased bone density, osteoporosis, fracture, acne, and infections. |
| Level of international normalized ratio | At the 3rd postoperative month | Level of international normalized ratio |
| Rate of newly-developed diabetes insipidus | 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. |
Countries
China
Contacts
Primary ContactBing Xing, MD
Backup ContactXiaopeng Guo, MD
Outcome results
None listed