Trial Outcomes & Findings for Evaluation of Etomidate on Adrenal Function in Trauma Patients (NCT NCT00462644)

NCT ID: NCT00462644

Last Updated: 2010-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test
• Results posted on: 2010-02-23

Participant Flow

Adult trauma patients admitted to Erlanger Health System's Level I trauma center requiring rapid sequence induction were randomized to one of two approved drug treatment regimens.

72 hour waiver of consent granted by the Institutional Review Board (IRB)

Participant milestones

Measure	Etomidate Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Overall Study STARTED	18	12
Overall Study COMPLETED	18	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Etomidate on Adrenal Function in Trauma Patients

Baseline characteristics by cohort

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	10 Participants n=7 Participants	24.0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6.0 Participants n=5 Participants
Age Continuous	41.8 years STANDARD_DEVIATION 24.5 • n=5 Participants	43.9 years STANDARD_DEVIATION 19.5 • n=7 Participants	42.6 years STANDARD_DEVIATION 22.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	11.0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19.0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	12 participants n=7 Participants	30.0 participants n=5 Participants

PRIMARY outcome

Timeframe: pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: postintubation (baseline cortisol level)

cortisol level after randomization and rapid sequence induction

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Postintubation Cortisol (Baseline Cortisol Level)	18.2 micrograms/dL Standard Deviation 8.4	27.9 micrograms/dL Standard Deviation 13.4

PRIMARY outcome

Timeframe: 4-6hr after RSI

change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Change in Baseline Cortisol	-12.8 micrograms/dL Standard Deviation 9.6	1.1 micrograms/dL Standard Deviation 7.6

PRIMARY outcome

Timeframe: 60 minutes after administration of cotrosyn

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)	22.91 micrograms/dL Standard Deviation 10.4	39.09 micrograms/dL Standard Deviation 10.8

SECONDARY outcome

Timeframe: time to hospital discharge in days

days from admission to hospital discharge

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Hospital Length of Stay	13.9 days Standard Deviation 9.5	6.4 days Standard Deviation 4.4

SECONDARY outcome

Timeframe: time from hospital admission to transfer out of ICU to floor bed

ICU length of stay in days

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Intensive Care Unit (ICU) Length of Stay	8.1 days Standard Deviation 7.2	3.0 days Standard Deviation 2.4

SECONDARY outcome

Timeframe: time from intubation to extubation

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Ventilator Days	6.3 days Standard Deviation 6.5	1.5 days Standard Deviation 0.8

SECONDARY outcome

Timeframe: death in hospital

deaths

Outcome measures

Measure	Etomidate n=18 Participants Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 Participants Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Number of Deaths	2 participants	0 participants

Adverse Events

Etomidate

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl-Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etomidate n=18 participants at risk Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications	Fentanyl-Midazolam n=12 participants at risk Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Cardiac disorders death	11.1% 2/18 • Number of events 2 • from intubation until hospital discharge Two deaths occurred during hospitalization, but were not due to any study procedures. Deaths were due to trauma injuries sustained in conjunction with pre-existing conditions.	0.00% 0/12 • from intubation until hospital discharge Two deaths occurred during hospitalization, but were not due to any study procedures. Deaths were due to trauma injuries sustained in conjunction with pre-existing conditions.

Other adverse events

Adverse event data not reported

Additional Information

Amy N. Hildreth, MD

Wake Forest University, Department of Surgery

Email: ahildret@gmail.com

Results disclosure agreements

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