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Peri-Operative Steroid Management in Patients (Steroid)

Primary Purpose

Pituitary Adenoma, Pituitary Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hydrocortisone
dexamethasone
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring pituitary adenoma, Pituitary Tumor, transsphenoidal resection, pituitary cyst

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection.

Exclusion Criteria:

  • Patients with Cushing's Disease (pituitary tumor which secretes ACTH)
  • Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism)
  • Patients on long term glucocorticoid therapy
  • Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

steroid treatment arm

non-steroid treatment

Arm Description

Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg

Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).

Outcomes

Primary Outcome Measures

Number of Participants With Adrenal Insufficiency
Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test

Secondary Outcome Measures

Percentage of Patients Discharged on Glucocorticoids
Patient charts were reviewed to identify patients who were discharged on prednisone

Full Information

First Posted
March 5, 2014
Last Updated
March 15, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02084134
Brief Title
Peri-Operative Steroid Management in Patients
Acronym
Steroid
Official Title
The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole. Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches. Objectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes
Detailed Description
Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma, Pituitary Diseases
Keywords
pituitary adenoma, Pituitary Tumor, transsphenoidal resection, pituitary cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
steroid treatment arm
Arm Type
Active Comparator
Arm Description
Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg
Arm Title
non-steroid treatment
Arm Type
No Intervention
Arm Description
Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Other Intervention Name(s)
intravenous hydrocortisone
Intervention Description
100mg at the time of surgery
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
intravenous dexamethasone
Intervention Description
0.5mg every 6 hours for a total of four doses
Primary Outcome Measure Information:
Title
Number of Participants With Adrenal Insufficiency
Description
Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test
Time Frame
6 weeks following surgery
Secondary Outcome Measure Information:
Title
Percentage of Patients Discharged on Glucocorticoids
Description
Patient charts were reviewed to identify patients who were discharged on prednisone
Time Frame
1 day (Day of hospital discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection. Exclusion Criteria: Patients with Cushing's Disease (pituitary tumor which secretes ACTH) Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism) Patients on long term glucocorticoid therapy Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M. Silverstein, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15163331
Citation
Agha A, Liew A, Finucane F, Baker L, O'Kelly P, Tormey W, Thompson CJ. Conventional glucocorticoid replacement overtreats adult hypopituitary patients with partial ACTH deficiency. Clin Endocrinol (Oxf). 2004 Jun;60(6):688-93. doi: 10.1111/j.1365-2265.2004.02035.x.
Results Reference
background
PubMed Identifier
20339931
Citation
Marko NF, Hamrahian AH, Weil RJ. Immediate postoperative cortisol levels accurately predict postoperative hypothalamic-pituitary-adrenal axis function after transsphenoidal surgery for pituitary tumors. Pituitary. 2010 Sep;13(3):249-55. doi: 10.1007/s11102-010-0227-6.
Results Reference
background
PubMed Identifier
19326985
Citation
Marko NF, Gonugunta VA, Hamrahian AH, Usmani A, Mayberg MR, Weil RJ. Use of morning serum cortisol level after transsphenoidal resection of pituitary adenoma to predict the need for long-term glucocorticoid supplementation. J Neurosurg. 2009 Sep;111(3):540-4. doi: 10.3171/2008.12.JNS081265.
Results Reference
background
PubMed Identifier
3372683
Citation
Hout WM, Arafah BM, Salazar R, Selman W. Evaluation of the hypothalamic-pituitary-adrenal axis immediately after pituitary adenomectomy: is perioperative steroid therapy necessary? J Clin Endocrinol Metab. 1988 Jun;66(6):1208-12. doi: 10.1210/jcem-66-6-1208.
Results Reference
background
PubMed Identifier
19052341
Citation
Bhansali A, Dutta P, Bhat MH, Mukherjee KK, Rajput R, Bhadada S. Rational use of glucocorticoid during pituitary surgery--a pilot study. Indian J Med Res. 2008 Sep;128(3):294-9.
Results Reference
background
PubMed Identifier
12050244
Citation
Inder WJ, Hunt PJ. Glucocorticoid replacement in pituitary surgery: guidelines for perioperative assessment and management. J Clin Endocrinol Metab. 2002 Jun;87(6):2745-50. doi: 10.1210/jcem.87.6.8547.
Results Reference
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Links:
URL
https://vfh.wustl.edu/
Description
Washington University School of Medicine, Research Participant Registry

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Peri-Operative Steroid Management in Patients

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