Clinical trial NCT00462644: Evaluation of Etomidate on Adrenal Function in Trauma Patients
Official title: A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: adrenal insufficiency
etomidate
rapid sequence induction
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2007-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in trauma patients.

Detailed description: The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for RSI. Both drug regimens have a rapid onset, short duration and short half-life.

Patients will be randomly assigned to one arm of the study. The trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. The numbers will correspond to a log, delineating which medication is given. The nurse will document the medication as RSI Study Drug - etomidate or RSI Study Drug - standard and the randomization packet number (ie, RSI Study Drug, etomidate, #1, RSI Study Drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the ER Resuscitation Bay.

Baseline cortisol level will be drawn prior to RSI. An additional cortisol level will be drawn 4-6 hours later. Following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn IV and rechecking a cortisol level in 60 minutes. Adrenal insufficiency will be defined as a baseline cortisol level of \<15 or an increase in cortisol of \<9 after cortrosyn administration. Patients will be monitored for 24 hours for hemodynamics, IV fluid administration , and use of vasopressors. Patient will be resuscitated to adequate mean arterial blood pressure and urine output. Any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg IV every 6 hours.

Eligibility criteria: Inclusion Criteria:

* Trauma mechanism of injury
* Patient requires rapid sequence induction for ventilatory support

Exclusion Criteria:

* \<18 years old
* Prisoners
* Pregnant women
* Patients with a history of adrenal insufficiency
* Patients with adrenal trauma documented by CT scan
* Patients receiving corticosteroids in the previous year

Primary outcomes:
measure: Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test
timeFrame: pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test
measure: Postintubation Cortisol (Baseline Cortisol Level)
timeFrame: postintubation (baseline cortisol level)
measure: Change in Baseline Cortisol
timeFrame: 4-6hr after RSI
measure: Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)
timeFrame: 60 minutes after administration of cotrosyn
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: time to hospital discharge in days
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: time from hospital admission to transfer out of ICU to floor bed
measure: Ventilator Days
timeFrame: time from intubation to extubation
measure: Number of Deaths
timeFrame: death in hospital
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Vicente A Mejia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hildreth AN, Mejia VA, Maxwell RA, Smith PW, Dart BW, Barker DE. Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study. J Trauma. 2008 Sep;65(3):573-9. doi: 10.1097/TA.0b013e31818255e8.