Evaluation of Etomidate on Adrenal Function in Trauma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study

Conditions
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Adrenal Insufficiency

Intervention / Treatment
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* Drug: RSI sedation with etomidate/succinylcholine
* Drug: RSI sedation with fentanyl/midazolam/succinylcholine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etomidate<br>Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications | Drug: RSI sedation with etomidate/succinylcholine<br>* etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV<br>|
| Active Comparator: Fentanyl-Midazolam<br>Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications. | Drug: RSI sedation with fentanyl/midazolam/succinylcholine<br>* 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test |  | pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test | 
| Postintubation Cortisol (Baseline Cortisol Level) | cortisol level after randomization and rapid sequence induction | postintubation (baseline cortisol level) | 
| Change in Baseline Cortisol | change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test) | 4-6hr after RSI | 
| Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) |  | 60 minutes after administration of cotrosyn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | days from admission to hospital discharge | time to hospital discharge in days | 
| Intensive Care Unit (ICU) Length of Stay | ICU length of stay in days | time from hospital admission to transfer out of ICU to floor bed | 
| Ventilator Days |  | time from intubation to extubation | 
| Number of Deaths | deaths | death in hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adrenal insufficiency, etomidate, rapid sequence induction