Evaluation of Etomidate on Adrenal Function in Trauma Patients
Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adrenal Insufficiency
Intervention: RSI sedation with etomidate/succinylcholine (Drug); RSI sedation with fentanyl/midazolam/succinylcholine (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Tennessee Official(s) and/or principal investigator(s): Vicente A Mejia, MD, Principal Investigator, Affiliation: University of Tennessee
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.
Clinical Details
Official title: A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation TestPostintubation Cortisol (Baseline Cortisol Level) Change in Baseline Cortisol Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)
Secondary outcome: Hospital Length of StayIntensive Care Unit (ICU) Length of Stay Ventilator Days Number of Deaths
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Erlanger Medical Center, Chattanooga, Tennessee 37403, United States
Additional Information
Starting date: February 2006
Last updated: February 17, 2010
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