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Evaluation of Etomidate on Adrenal Function in Trauma Patients

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ClinicalTrials.gov Identifier: NCT00462644
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : November 11, 2009
Last Update Posted : February 23, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Drug: RSI sedation with etomidate/succinylcholine Drug: RSI sedation with fentanyl/midazolam/succinylcholine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
Study Start Date : February 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : September 2006

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

Primary Outcome Measures :
  1. Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test [ Time Frame: pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test ]
  2. Postintubation Cortisol (Baseline Cortisol Level) [ Time Frame: postintubation (baseline cortisol level) ]
    cortisol level after randomization and rapid sequence induction

  3. Change in Baseline Cortisol [ Time Frame: 4-6hr after RSI ]
    change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)

  4. Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) [ Time Frame: 60 minutes after administration of cotrosyn ]

Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: time to hospital discharge in days ]
    days from admission to hospital discharge

  2. Intensive Care Unit (ICU) Length of Stay [ Time Frame: time from hospital admission to transfer out of ICU to floor bed ]
    ICU length of stay in days

  3. Ventilator Days [ Time Frame: time from intubation to extubation ]
  4. Number of Deaths [ Time Frame: death in hospital ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462644

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United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
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Principal Investigator: Vicente A Mejia, MD University of Tennessee
Publications of Results:
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Responsible Party: Vicente A. Mejia, MD, University of Tennessee College of Medicine, Chattanooga
ClinicalTrials.gov Identifier: NCT00462644    
Other Study ID Numbers: 05-050
First Posted: April 19, 2007    Key Record Dates
Results First Posted: November 11, 2009
Last Update Posted: February 23, 2010
Last Verified: February 2010
Keywords provided by University of Tennessee:
adrenal insufficiency
rapid sequence induction
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents