Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 115 for:    cancer | butyrate

Peri-Operative Steroid Management in Patients (Steroid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084134
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : March 1, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 11, 2014
Results First Submitted Date  ICMJE January 31, 2018
Results First Posted Date  ICMJE March 1, 2018
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Number of Participants With Adrenal Insufficiency [ Time Frame: 6 weeks following surgery ]
Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
Incidence of adrenal insufficiency in follow-up [ Time Frame: 6 weeks following surgery ]
Assessed by the cosyntropin stimulation test
Change History Complete list of historical versions of study NCT02084134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
Percentage of Patients Discharged on Glucocorticoids [ Time Frame: 1 day (Day of hospital discharge) ]
Patient charts were reviewed to identify patients who were discharged on prednisone
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Quality of Life [ Time Frame: 6 weeks post-operative ]
    As measured by SF-36 questionnaire and Headache Pain Scale
  • Rate of perioperative complications [ Time Frame: Participants will be followed for the perioperative period, an expected average of 8 weeks ]
    Length of hospital stay, bleeding, infection, hyperglycemia, development of diabetes insipidus, average blood glucose
  • Percentage of Patients Discharged on Glucocorticoids [ Time Frame: 1 day (Day of hospital discharge) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peri-Operative Steroid Management in Patients
Official Title  ICMJE The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Pituitary Adenoma
  • Pituitary Diseases
Intervention  ICMJE
  • Drug: hydrocortisone
    100mg at the time of surgery
    Other Name: intravenous hydrocortisone
  • Drug: dexamethasone
    0.5mg every 6 hours for a total of four doses
    Other Name: intravenous dexamethasone
Study Arms  ICMJE
  • Active Comparator: steroid treatment arm
    Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg
    Interventions:
    • Drug: hydrocortisone
    • Drug: dexamethasone
  • No Intervention: non-steroid treatment
    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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
43
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2014)
30
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02084134
Other Study ID Numbers  ICMJE 201110174
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie M. Silverstein, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP