Peri-Operative Steroid Management in Patients

NCT02084134 | Completed Results DMC

• 1 other identifier: 201110174
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Pituitary Adenoma; Pituitary Diseases

Keywords

pituitary adenoma; Pituitary Tumor; transsphenoidal resection; pituitary cyst

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adrenal Insufficiency

  Adrenal insufficiency was defined by a 30 or 60 min cortisol \< 18 during a cosyntropin stimulation test

  6 weeks following surgery

Secondary Outcomes (1)

• Percentage of Patients Discharged on Glucocorticoids

  1 day (Day of hospital discharge)

Study Arms (2)

steroid treatment arm

ACTIVE COMPARATOR

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

Drug: hydrocortisone; Drug: dexamethasone

non-steroid treatment

NO INTERVENTION

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).

Interventions

hydrocortisone DRUG

100mg at the time of surgery

Also known as: intravenous hydrocortisone

steroid treatment arm

dexamethasone DRUG

0.5mg every 6 hours for a total of four doses

Also known as: intravenous dexamethasone

steroid treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• 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.

  PMID: 15163331 BACKGROUND

• 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.

  PMID: 20339931 BACKGROUND

• 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.

  PMID: 19326985 BACKGROUND

• 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.

  PMID: 3372683 BACKGROUND

• 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.

  PMID: 19052341 BACKGROUND

• 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.

  PMID: 12050244 BACKGROUND

Related Links

• Washington University School of Medicine, Research Participant Registry

MeSH Terms

Conditions

Pituitary Neoplasms; Pituitary Diseases

Interventions

Hydrocortisone; Dexamethasone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienetriols; Pregnadienes; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Julie Silverstein
• Organization: Washington University School of Medicine

jsilverstein@wustl.edu

314-747-7006

Study Officials

• Julie M. Silverstein, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2012
• Primary Completion: November 21, 2016
• Study Completion: December 31, 2016
• Last Updated: April 11, 2018
• Results First Posted: March 1, 2018

Record last verified: 2018-03

Locations

US (1)