Evaluation of Etomidate on Adrenal Function in Trauma Patients

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462644
• Other study ID #: 05-050
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: February 17, 2010
• Start date: February 2006
• Est. completion date: September 2006

Study information

• Verified date: February 2010
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Drug:
• RSI sedation with etomidate/succinylcholine
etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
• RSI sedation with fentanyl/midazolam/succinylcholine
100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

Locations

Country	Name	City	State
United States	Erlanger Medical Center	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test		pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test	No
Primary	Postintubation Cortisol (Baseline Cortisol Level)		postintubation (baseline cortisol level)	No
Primary	Change in Baseline Cortisol		4-6hr after RSI	No
Primary	Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)		60 minutes after administration of cotrosyn	No
Secondary	Hospital Length of Stay		time to hospital discharge in days	No
Secondary	Intensive Care Unit (ICU) Length of Stay		time from hospital admission to transfer out of ICU to floor bed	No
Secondary	Ventilator Days		time from intubation to extubation	No
Secondary	Number of Deaths		death in hospital	No