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Peri-Operative Steroid Management in Patients (Steroid)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Pituitary Adenoma
Pituitary Diseases
Interventions Drug: hydrocortisone
Drug: dexamethasone
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Steroid Treatment Arm Non-steroid Treatment
Hide Arm/Group Description

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

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

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).
Period Title: Overall Study
Started 23 20
Completed 19 17
Not Completed 4 3
Reason Not Completed
Protocol Violation             4             2
Death             0             1
Arm/Group Title Steroid Treatment Arm Non-steroid Treatment Total
Hide Arm/Group Description

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

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

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). Total of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  89.5%
15
  88.2%
32
  88.9%
>=65 years
2
  10.5%
2
  11.8%
4
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
7
  36.8%
10
  58.8%
17
  47.2%
Male
12
  63.2%
7
  41.2%
19
  52.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 36 participants
19 17 36
1.Primary Outcome
Title Number of Participants With Adrenal Insufficiency
Hide Description Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test
Time Frame 6 weeks following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Steroid Treatment Arm Non-steroid Treatment
Hide Arm/Group Description:

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

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

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).
Overall Number of Participants Analyzed 19 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.5%
1
   5.9%
2.Secondary Outcome
Title Percentage of Patients Discharged on Glucocorticoids
Hide Description Patient charts were reviewed to identify patients who were discharged on prednisone
Time Frame 1 day (Day of hospital discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Steroid Treatment Arm Non-steroid Treatment
Hide Arm/Group Description:

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

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

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).
Overall Number of Participants Analyzed 19 17
Measure Type: Count of Participants
Unit of Measure: Participants
8
  42.1%
2
  11.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Steroid Treatment Arm Non-steroid Treatment
Hide Arm/Group Description

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

hydrocortisone: 100mg at the time of surgery

dexamethasone: 0.5mg every 6 hours for a total of four doses

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).
All-Cause Mortality
Steroid Treatment Arm Non-steroid Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Steroid Treatment Arm Non-steroid Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      1/20 (5.00%)    
Immune system disorders     
Death [1]  0/23 (0.00%)  0 1/20 (5.00%)  1
[1]
One patient in non-steroid group died from meningitis which was not felt to be related to the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Steroid Treatment Arm Non-steroid Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/20 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julie Silverstein
Organization: Washington University School of Medicine
Phone: 314-747-7006
EMail: jsilverstein@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02084134     History of Changes
Other Study ID Numbers: 201110174
First Submitted: March 5, 2014
First Posted: March 11, 2014
Results First Submitted: January 31, 2018
Results First Posted: March 1, 2018
Last Update Posted: April 11, 2018