Evaluation of Etomidate on Adrenal Function in Trauma Patients

This study has been completed.
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00462644
First received: April 17, 2007
Last updated: February 17, 2010
Last verified: February 2010
  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: RSI sedation with etomidate/succinylcholine
Drug: RSI sedation with fentanyl/midazolam/succinylcholine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Postintubation Cortisol (Baseline Cortisol Level) [ Time Frame: postintubation (baseline cortisol level) ] [ Designated as safety issue: No ]
  • Change in Baseline Cortisol [ Time Frame: 4-6hr after RSI ] [ Designated as safety issue: No ]
  • Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) [ Time Frame: 60 minutes after administration of cotrosyn ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: time to hospital discharge in days ] [ Designated as safety issue: No ]
  • Intensive Care Unit (ICU) Length of Stay [ Time Frame: time from hospital admission to transfer out of ICU to floor bed ] [ Designated as safety issue: No ]
  • Ventilator Days [ Time Frame: time from intubation to extubation ] [ Designated as safety issue: No ]
  • Number of Deaths [ Time Frame: death in hospital ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2006
Study Completion Date: September 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Vicente A. Mejia, MD, University of Tennessee College of Medicine, Chattanooga
ClinicalTrials.gov Identifier: NCT00462644     History of Changes
Other Study ID Numbers: 05-050
Study First Received: April 17, 2007
Results First Received: March 4, 2009
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Adrenal Insufficiency
Addison Disease
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Succinylcholine
Fentanyl
Midazolam
Etomidate
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 24, 2014