Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462644
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2007-04-17
Brief Title:
Evaluation of Etomidate on Adrenal Function in Trauma Patients
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 03 mgkg and succinylcholine 1mgkg 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 patients 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 025 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
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 patients 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 025 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None