Adrenal InsufficiencyNCT00462644
Evaluation of Etomidate on Adrenal Function in Trauma Patients
A study testing RSI sedation with etomidate/succinylcholine and RSI sedation with fentanyl/midazolam/succinylcholine in people with Adrenal Insufficiency, run by University of Tennessee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- RSI sedation with etomidate/succinylcholine and RSI sedation with fentanyl/midazolam/succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma mechanism of injury
- Patient requires rapid sequence induction for ventilatory support
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Medical Center
Chattanooga, Tennessee, 37403
About this study
Official title: A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
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.
Read the 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
- Being tested
- RSI sedation with etomidate/succinylcholine, RSI sedation with fentanyl/midazolam/succinylcholine
- Keywords
- adrenal insufficiency, etomidate, rapid sequence induction
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSI sedation with etomidate/succinylcholineDrug
etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV
RSI sedation with fentanyl/midazolam/succinylcholineDrug
100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Active comparator | Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications Receives: Drug: RSI sedation with etomidate/succinylcholine |
| 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. Receives: Drug: RSI sedation with fentanyl/midazolam/succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test
Measured: 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
Measured: 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)
Measured: 4-6hr after RSI
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)
Measured: 60 minutes after administration of cotrosyn
Secondary outcomes (4)
Hospital Length of Stay
days from admission to hospital discharge
Measured: time to hospital discharge in days
Intensive Care Unit (ICU) Length of Stay
ICU length of stay in days
Measured: time from hospital admission to transfer out of ICU to floor bed
Ventilator Days
Measured: time from intubation to extubation
Number of Deaths
deaths
Measured: death in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startFeb 2006
- Primary completionAug 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Investigators
- Vicente A Mejia, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462644
- Sponsor's protocol ID
- 05-050
- Status last verified
- Feb 2010
- First submitted
- 17 Apr 2007
- Last updated
- 23 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18784570
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00462644
- Acronym / sponsor ID
- 05-050
- Conditions
- Adrenal Insufficiency
- Keywords
- adrenal insufficiency, etomidate, rapid sequence induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 11 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Active comparator | Drug: RSI sedation with etomidate/succinylcholineEtomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications |
| Fentanyl-Midazolam | Active comparator | Drug: RSI sedation with fentanyl/midazolam/succinylcholineFentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trauma mechanism of injury
- Patient requires rapid sequence induction for ventilatory support
Key exclusion criteria (6 listed)
- <18 years old
- Prisoners
- Pregnant women
- Patients with a history of adrenal insufficiency
- Patients with adrenal trauma documented by CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSI sedation with etomidate/succinylcholineetomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV | Drug | Etomidate |
| RSI sedation with fentanyl/midazolam/succinylcholine100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV | Drug | Fentanyl-Midazolam |
Primary outcome
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
Postintubation Cortisol (Baseline Cortisol Level)
Time frame: postintubation (baseline cortisol level)
cortisol level after randomization and rapid sequence induction
Change in Baseline Cortisol
Time frame: 4-6hr after RSI
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)
Time frame: 60 minutes after administration of cotrosyn
4 secondary outcomes
Hospital Length of Stay
Time frame: time to hospital discharge in days
Intensive Care Unit (ICU) Length of Stay
Time frame: time from hospital admission to transfer out of ICU to floor bed
Ventilator Days
Time frame: time from intubation to extubation
Number of Deaths
Time frame: death in hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18784570Hildreth 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente A Mejia, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSI sedation with etomidate/succinylcholine and RSI sedation with fentanyl/midazolam/succinylcholine in people with Adrenal Insufficiency, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.