Evaluation of Etomidate on Adrenal Function in Trauma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency
• Intervention / Treatment: Drug: RSI sedation with etomidate/succinylcholine; Drug: RSI sedation with fentanyl/midazolam/succinylcholine

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Etomidate; 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; etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
Active Comparator: 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.	Drug: RSI sedation with fentanyl/midazolam/succinylcholine; 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Vicente A Mejia, MD, University of Tennessee

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: April 17, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimate): April 19, 2007

Study Record Updates

• Last Update Posted (Estimate): February 23, 2010
• Last Update Submitted That Met QC Criteria: February 17, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: etomidate; adrenal insufficiency; rapid sequence induction
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenal Insufficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Fentanyl; Midazolam; Etomidate; Succinylcholine
• Other Study ID Numbers: 05-050