The Effect of Etomidate on Outcomes of Trauma Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Erik Kulstad, MD, MS, Advocate Hospital System
ClinicalTrials.gov Identifier:
NCT00938990
First received: July 13, 2009
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Trauma
Drug: Etomidate
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: The Effect of Etomidate on Outcomes of Trauma Patients

Resource links provided by NLM:


Further study details as provided by Advocate Hospital System:

Primary Outcome Measures:
  • Length of Stay [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Active Comparator: Midazolam Drug: Midazolam
Experimental: Etomidate Drug: Etomidate

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Erik Kulstad, MD, MS, Research Director, Advocate Hospital System
ClinicalTrials.gov Identifier: NCT00938990     History of Changes
Other Study ID Numbers: 4667 - ACH IRB
Study First Received: July 13, 2009
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wounds and Injuries
Etomidate
Midazolam
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014