Evaluation of Etomidate on Adrenal Function in Trauma Patients

NCT ID: NCT00462644

Last Updated: 2010-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-09-30

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 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.

Conditions

Adrenal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Etomidate

Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications

Group Type: ACTIVE_COMPARATOR

RSI sedation with etomidate/succinylcholine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

RSI sedation with fentanyl/midazolam/succinylcholine

Intervention Type: DRUG

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

Interventions

RSI sedation with etomidate/succinylcholine

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

Intervention Type: DRUG

RSI sedation with fentanyl/midazolam/succinylcholine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

University of Tennessee College of Medicine, Chattanooga

Principal Investigators

Vicente A Mejia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

Erlanger Medical Center

Chattanooga, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18784570 (View on PubMed)

Other Identifiers

05-050

Identifier Type: -

Identifier Source: org_study_id