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Evaluation of Etomidate on Adrenal Function in Trauma Patients

Primary Purpose

Adrenal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RSI sedation with etomidate/succinylcholine
RSI sedation with fentanyl/midazolam/succinylcholine
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adrenal Insufficiency focused on measuring adrenal insufficiency, etomidate, rapid sequence induction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erlanger Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Etomidate

Fentanyl-Midazolam

Arm Description

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

Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.

Outcomes

Primary Outcome Measures

Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test
Postintubation Cortisol (Baseline Cortisol Level)
cortisol level after randomization and rapid sequence induction
Change in Baseline Cortisol
change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)

Secondary Outcome Measures

Hospital Length of Stay
days from admission to hospital discharge
Intensive Care Unit (ICU) Length of Stay
ICU length of stay in days
Ventilator Days
Number of Deaths
deaths

Full Information

First Posted
April 17, 2007
Last Updated
February 17, 2010
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT00462644
Brief Title
Evaluation of Etomidate on Adrenal Function in Trauma Patients
Official Title
A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
Keywords
adrenal insufficiency, etomidate, rapid sequence induction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Active Comparator
Arm Description
Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
Arm Title
Fentanyl-Midazolam
Arm Type
Active Comparator
Arm Description
Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Intervention Type
Drug
Intervention Name(s)
RSI sedation with etomidate/succinylcholine
Intervention Description
etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
Intervention Type
Drug
Intervention Name(s)
RSI sedation with fentanyl/midazolam/succinylcholine
Intervention Description
100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV
Primary Outcome Measure Information:
Title
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
Title
Postintubation Cortisol (Baseline Cortisol Level)
Description
cortisol level after randomization and rapid sequence induction
Time Frame
postintubation (baseline cortisol level)
Title
Change in Baseline Cortisol
Description
change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)
Time Frame
4-6hr after RSI
Title
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)
Time Frame
60 minutes after administration of cotrosyn
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
days from admission to hospital discharge
Time Frame
time to hospital discharge in days
Title
Intensive Care Unit (ICU) Length of Stay
Description
ICU length of stay in days
Time Frame
time from hospital admission to transfer out of ICU to floor bed
Title
Ventilator Days
Time Frame
time from intubation to extubation
Title
Number of Deaths
Description
deaths
Time Frame
death in hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente A Mejia, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18784570
Citation
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.
Results Reference
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Evaluation of Etomidate on Adrenal Function in Trauma Patients

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