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Evaluation of Etomidate on Adrenal Function in Trauma Patients

Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adrenal Insufficiency

Intervention: RSI sedation with etomidate/succinylcholine (Drug); RSI sedation with fentanyl/midazolam/succinylcholine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Tennessee

Official(s) and/or principal investigator(s):
Vicente A Mejia, MD, Principal Investigator, Affiliation: University of Tennessee

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test

Postintubation Cortisol (Baseline Cortisol Level)

Change in Baseline Cortisol

Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)

Secondary outcome:

Hospital Length of Stay

Intensive Care Unit (ICU) Length of Stay

Ventilator Days

Number of Deaths

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Erlanger Medical Center, Chattanooga, Tennessee 37403, United States
Additional Information

Starting date: February 2006
Last updated: February 17, 2010

Page last updated: August 23, 2015

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