Evaluation of Etomidate on Adrenal Function in Trauma Patients

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]
   deaths

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications of Results:

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.

• 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
• Results First Posted: November 11, 2009
• Last Update Posted: February 23, 2010
• Last Verified: February 2010

Keywords provided by University of Tennessee:

adrenal insufficiency; etomidate; rapid sequence induction

Additional relevant MeSH terms:

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Fentanyl; Midazolam; Etomidate; Succinylcholine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; 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