Trial Outcomes & Findings for Peri-Operative Steroid Management in Patients (NCT NCT02084134)

NCT ID: NCT02084134

Last Updated: 2018-04-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 weeks following surgery
• Results posted on: 2018-04-11

Participant Flow

Participant milestones

Measure	Steroid Treatment Arm 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	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).
Overall Study STARTED	23	20
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Steroid Treatment Arm 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	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).
Overall Study Protocol Violation	4	2
Overall Study Death	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Steroid Treatment Arm n=19 Participants 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	Non-steroid Treatment n=17 Participants 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 n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=19 Participants	0 Participants n=17 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=19 Participants	15 Participants n=17 Participants	32 Participants n=36 Participants
Age, Categorical >=65 years	2 Participants n=19 Participants	2 Participants n=17 Participants	4 Participants n=36 Participants
Sex: Female, Male Female	7 Participants n=19 Participants	10 Participants n=17 Participants	17 Participants n=36 Participants
Sex: Female, Male Male	12 Participants n=19 Participants	7 Participants n=17 Participants	19 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	19 participants n=19 Participants	17 participants n=17 Participants	36 participants n=36 Participants

PRIMARY outcome

Timeframe: 6 weeks following surgery

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

Outcome measures

Measure	Steroid Treatment Arm n=19 Participants 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	Non-steroid Treatment n=17 Participants 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).
Number of Participants With Adrenal Insufficiency	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 day (Day of hospital discharge)

Patient charts were reviewed to identify patients who were discharged on prednisone

Outcome measures

Measure	Steroid Treatment Arm n=19 Participants 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	Non-steroid Treatment n=17 Participants 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).
Percentage of Patients Discharged on Glucocorticoids	8 Participants	2 Participants

Adverse Events

Steroid Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-steroid Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Steroid Treatment Arm n=23 participants at risk 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	Non-steroid Treatment n=20 participants at risk 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).
Immune system disorders Death	0.00% 0/23	5.0% 1/20 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Silverstein

Washington University School of Medicine

Phone: 314-747-7006

Email: jsilverstein@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place