TraumaNCT00938990
The Effect of Etomidate on Outcomes of Trauma Patients
A study testing Etomidate and Midazolam in people with Trauma, run by Advocate Hospital System.
Trial summary
Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Etomidate and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- All critically ill trauma patients (defined as patients over the age of 14 years requiring trauma team activation) who present to the ED in need of ventilatory support due to the severity of their illness and injuries.
Who cannot join
- Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ED.
About this study
Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents.
Research Hypothesis: The investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction.
Read more
Specific Aims: The specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. The investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. The investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized.
Significance: If the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. Since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
| Etomidate | Experimental | Not described Receives: Drug: Etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advocate Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Kulstad, MD, MS, Advocate Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938990
- Sponsor's protocol ID
- 4667 - ACH IRB
- Status last verified
- Nov 2011
- First submitted
- 13 Jul 2009
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Etomidate on Outcomes of Trauma Patients
- ClinicalTrials.gov ID
- NCT00938990
- Acronym / sponsor ID
- 4667 - ACH IRB
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Advocate Hospital SystemUniversity, hospital or other
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents.
Research Hypothesis: The investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction.
Specific Aims: The specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. The investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. The investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized.
Significance: If the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. Since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: Midazolam |
| Etomidate | Experimental | Drug: Etomidate |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All critically ill trauma patients (defined as patients over the age of 14 years requiring trauma team activation) who present to the ED in need of ventilatory support due to the severity of their illness and injuries.
Key exclusion criteria (1 listed)
- Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ED.
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 |
|---|---|---|
| Etomidate | Drug | Etomidate |
| Midazolam | Drug | Midazolam |
Primary outcome
Length of Stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate and Midazolam in people with Trauma, run by Advocate Hospital System.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Length of Stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2011.