The Effect of Etomidate on Outcomes of Trauma Patients

NCT00938990 | Withdrawn

• 1 other identifier: 4667 - ACH IRB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• Length of Stay

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Etomidate

EXPERIMENTAL

Drug: Etomidate

Interventions

Etomidate DRUG

Etomidate

Midazolam DRUG

Midazolam

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age less than 14, do-not-resuscitate status, or cardiopulmonary arrest prior to arrival in the ED.

Sponsors & Collaborators

• Advocate Hospital System: lead

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Etomidate; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Last Updated: December 1, 2011

Record last verified: 2011-11