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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etomidate | Active Comparator | Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications |
|
| Fentanyl-Midazolam | Active Comparator | Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSI sedation with etomidate/succinylcholine | Drug | etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Postintubation Cortisol (Baseline Cortisol Level) | cortisol level after randomization and rapid sequence induction | postintubation (baseline cortisol level) |
| Change in Baseline Cortisol | change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test) | 4-6hr after RSI |
| Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) | 60 minutes after administration of cotrosyn |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | days from admission to hospital discharge | time to hospital discharge in days |
| Intensive Care Unit (ICU) Length of Stay | ICU length of stay in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente A Mejia, MD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18784570 | Result | 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. |
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72 hour waiver of consent granted by the Institutional Review Board (IRB)
Adult trauma patients admitted to Erlanger Health System's Level I trauma center requiring rapid sequence induction were randomized to one of two approved drug treatment regimens.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etomidate | Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etomidate | Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test | Not Posted | pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test | |||||||||||||
| Secondary | Hospital Length of Stay | days from admission to hospital discharge | Posted | Mean | Standard Deviation | days | time to hospital discharge in days |
from intubation until hospital discharge
Two deaths occurred during hospitalization, but were not due to any study procedures. Deaths were due to trauma injuries sustained in conjunction with pre-existing conditions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etomidate | Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Cardiac disorders | deaths occurred during hospitalization, but were not due to any study procedures. |
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Small trial most likely underpowered; large number of exclusions; other limitations discussed in published paper (PMID: 18784570).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy N. Hildreth, MD | Wake Forest University, Department of Surgery | ahildret@gmail.com |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D013390 | Succinylcholine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| RSI sedation with fentanyl/midazolam/succinylcholine | Drug | 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV |
|
| time from hospital admission to transfer out of ICU to floor bed |
| Ventilator Days | time from intubation to extubation |
| Number of Deaths | deaths | death in hospital |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Intensive Care Unit (ICU) Length of Stay | ICU length of stay in days | Posted | Mean | Standard Deviation | days | time from hospital admission to transfer out of ICU to floor bed |
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| Secondary | Ventilator Days | Posted | Mean | Standard Deviation | days | time from intubation to extubation |
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| Primary | Postintubation Cortisol (Baseline Cortisol Level) | cortisol level after randomization and rapid sequence induction | Posted | Mean | Standard Deviation | micrograms/dL | postintubation (baseline cortisol level) |
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| Primary | Change in Baseline Cortisol | change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test) | Posted | Mean | Standard Deviation | micrograms/dL | 4-6hr after RSI |
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| Primary | Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST) | Posted | Mean | Standard Deviation | micrograms/dL | 60 minutes after administration of cotrosyn |
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| Secondary | Number of Deaths | deaths | Posted | Number | participants | death in hospital |
|
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| 2 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 12 | 0 | 12 |
|
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| D002794 |
| Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| D010880 | Piperidines |