The Effect of Etomidate on Outcomes of Trauma Patients

Trauma Clinical Trial

Official title:

The Effect of Etomidate on Outcomes of Trauma Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00938990
• Other study ID #: 4667 - ACH IRB
• Status: Withdrawn
• Phase: N/A
• First received: July 13, 2009
• Last updated: November 30, 2011

Study information

• Verified date: November 2011
• Source: Advocate Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Drug:
• Etomidate

• Midazolam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Hospital System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay			Yes