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Sponsored by: |
University of Tennessee |
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Information provided by: | University of Tennessee |
ClinicalTrials.gov Identifier: | NCT00462644 |
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.
Condition | Intervention |
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Adrenal Insufficiency |
Drug: rapid sequence intubation sedation Drug: etomidate and succinylcholine Drug: versed and fentanyl Drug: succinylcholine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | September 2006 |
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 (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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Erlanger Medical Center | |
Chattanooga, Tennessee, United States, 37403 |
Principal Investigator: | Vicente A Mejia, MD | University of Tennessee |
Study ID Numbers: | 05-050 |
Study First Received: | April 17, 2007 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00462644 |
Health Authority: | United States: Institutional Review Board |
adrenal insufficiency, etomidate, rapid sequence induction |
Adrenal Insufficiency Addison's disease Fentanyl Autoimmune Diseases Wounds and Injuries Adrenal Gland Diseases Endocrine System Diseases Etomidate Midazolam |
Hypoadrenalism Adrenal gland hypofunction Succinylcholine Adrenoleukodystrophy Addison Disease Endocrinopathy Epinephrine X-linked adrenoleukodystrophy |
Anesthetics, Intravenous Immune System Diseases Physiological Effects of Drugs Neuromuscular Depolarizing Agents Anesthetics Central Nervous System Depressants Neuromuscular Blocking Agents |
Neuromuscular Agents Pharmacologic Actions Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Central Nervous System Agents |