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Evaluation of Etomidate on Adrenal Function in Trauma Patients
This study has been completed.
Sponsored by: University of Tennessee
Information provided by: University of Tennessee
ClinicalTrials.gov Identifier: NCT00462644
  Purpose

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 Intervention
Adrenal Insufficiency
Drug: rapid sequence intubation sedation
Drug: etomidate and succinylcholine
Drug: versed and fentanyl
Drug: succinylcholine

Genetics Home Reference related topics: X-linked adrenoleukodystrophy
MedlinePlus related topics: Injuries Wounds
Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Etomidate Epinephrine Epinephrine bitartrate Succinylcholine Succinylcholine chloride Suxamethonium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • cortisol levels pre and post rapid sequence induction and cortisol stimulation test

Secondary Outcome Measures:
  • hospital length of stay
  • ICU length of stay
  • ventilator days
  • survival status

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Study Completion Date: September 2006
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 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462644

Locations
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Vicente A Mejia, MD University of Tennessee
  More Information

Study ID Numbers: 05-050
Study First Received: April 17, 2007
Last Updated: April 18, 2007
ClinicalTrials.gov Identifier: NCT00462644  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
adrenal insufficiency, etomidate, rapid sequence induction

Study placed in the following topic categories:
Adrenal Insufficiency
Addison's disease
Fentanyl
Autoimmune Diseases
Wounds and Injuries
Adrenal Gland Diseases
Endocrine System Diseases
Etomidate
Midazolam
Hypoadrenalism
Adrenal gland hypofunction
Succinylcholine
Adrenoleukodystrophy
Addison Disease
Endocrinopathy
Epinephrine
X-linked adrenoleukodystrophy

Additional relevant MeSH terms:
Anesthetics, Intravenous
Immune System Diseases
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents
Anesthetics
Central Nervous System Depressants
Neuromuscular Blocking Agents
Neuromuscular Agents
Pharmacologic Actions
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009