Skip to main content
OpenTrials
Completed

NCT Number: NCT00462644

Evaluation of Etomidate on Adrenal Function in Trauma Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RSI sedation with etomidate/succinylcholine

Drug

etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV

RSI sedation with fentanyl/midazolam/succinylcholine

Drug

100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 19, 2007
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.