The Effect of Etomidate on Outcomes of Trauma Patients
Information source: Advocate Hospital System
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trauma
Intervention: Etomidate (Drug); Midazolam (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Advocate Hospital System
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. 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.
Clinical Details
Official title: The Effect of Etomidate on Outcomes of Trauma Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
Primary outcome: Length of Stay
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to
arrival in the ED.
Locations and Contacts
Additional Information
Last updated: November 30, 2011
|