Clinical Trial: Evaluation of Etomidate on Adrenal Function in Trauma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: University of Tennessee

Current Primary Outcome:

  • 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 ]
  • Postintubation Cortisol (Baseline Cortisol Level) [ Time Frame: postintubation (baseline cortisol level) ]
  • Change in Baseline Cortisol [ Time Frame: 4-6hr after RSI ]
  • Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) [ Time Frame: 60 minutes after administration of cotrosyn ]


Original Primary Outcome: Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test

Current Secondary Outcome:

  • Hospital Length of Stay [ Time Frame: time to hospital discharge in days ]
  • Intensive Care Unit (ICU) Length of Stay [ Time Frame: time from hospital admission to transfer out of ICU to floor bed ]
  • Ventilator Days [ Time Frame: time from intubation to extubation ]
  • Number of Deaths [ Time Frame: death in hospital ]


Original Secondary Outcome:

  • Hospital Length of Stay
  • ICU length of stay
  • Ventilator Days
  • survival status


Information By: University of Tennessee

Dates:
Date Received: April 17, 2007
Date Started: February 2006
Date Completion:
Last Updated: February 17, 2010
Last Verified: February 2010