Evaluation of Etomidate on Adrenal Function in Trauma Patients

Not Applicable

Completed

Conditions: Adrenal Insufficiency

Interventions: Drug: RSI sedation with etomidate/succinylcholine
Drug: RSI sedation with fentanyl/midazolam/succinylcholine

Registration Number: NCT00462644

Lead Sponsor: University of Tennessee

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate	RSI sedation with etomidate/succinylcholine	Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
Fentanyl-Midazolam	RSI sedation with fentanyl/midazolam/succinylcholine	Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.

Primary Outcome Measures

Name	Time	Method
Change in Baseline Cortisol	4-6hr after RSI	change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)	60 minutes after administration of cotrosyn
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)	postintubation (baseline cortisol level)	cortisol level after randomization and rapid sequence induction

Secondary Outcome Measures

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