The Effect of Etomidate on Patient Outcomes After Single Bolus Doses
Information source: Advocate Hospital System
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis; Trauma
Intervention: Etomidate (Drug); midazolam (Drug)
Sponsored by: Advocate Hospital System
Official(s) and/or principal investigator(s):
Erik B Kulstad, MD, MS, Study Chair, Affiliation: Advocate Christ Medical Center
The primary aim is to determine the difference in hospital length of stay between septic
patients given etomidate and those given midazolam for induction during rapid sequence
intubation (RSI) in the emergency department. To achieve this aim we plan to perform a
prospective randomized trial measuring the length of stay of patients meeting sepsis
criteria and requiring intubation. The investigators will compare in-hospital mortality
rates between patients given etomidate and patients given midazolam for induction. In
addition to hospital length of stay, secondary endpoints between the two groups will include
length of stay in the intensive care unit, death within 48 hours of admission, and total
number of days intubated.
In adult patients presenting to the emergency department with sepsis and requiring rapid
sequence intubation, the length of stay of patients given etomidate will be greater than
that of patients given the alternative agent midazolam for induction.
Official title: A Randomized Trial of Etomidate Versus Midazolam for Intubation of Patients With Sepsis.
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Length of Stay
Secondary outcome: Mortality
Rationale: Although the use of the drug etomidate for continuous sedation in mechanically
ventilated patients was found to have detrimental effects on patient mortality shortly after
its introduction into clinical practice, etomidate continues to be widely used as an
induction agent for endotracheal intubation. Recent data have called into question 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 an increase in vasopressor requirements and
hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, are
claimed by many authors to be safer than etomidate; however, no studies have formally
compared these agents.
Research Hypothesis: The investigators hypothesize that in critically ill adult patients
presenting to the emergency department with sepsis and requiring rapid sequence intubation,
the hospital length of stay of patients given etomidate will be increased compared to
patients given midazolam for induction.
Specific Aims: The specific aim is to determine the difference in hospital length of stay
between septic 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 length of hospital stay, length of ICU stay, and duration of intubation
by performing a prospective, randomized, trial of critically ill patients presenting to the
emergency department with sepsis 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 is found to adversely affect the length of stay of septic
patients, a reduction in the length of stay in such patients might be achieved by using
alternative agents for induction. The current widespread use of an induction agent that may
adversely affect the length of stay of septic patients has significant implications for
Minimum age: 18 Years.
Maximum age: N/A.
- All critically ill adult patients who present to the emergency department in need of
ventilatory support and having a traumatic or suspected infectious etiology for their
illness. Specifically, all patients meeting criteria for severe sepsis, septic
shock, or the sepsis syndrome by fulfillment of two of the four criteria for the
systemic inflammatory response syndrome (temperature greater than 38. 3°C or less than
36°C, heart rate greater than 90, respiratory rate greater than 20 or PaCO2 less than
32, white blood cell count greater than 12,000 or less than 4000 or greater than 10%
- All patients presenting in respiratory distress from a presumed pulmonary source of
infection and requiring ventilatory support.
- All patients presenting after any traumatic injury and requiring ventilatory support.
- An age less than 18
- Do-not-resuscitate status
Locations and Contacts
Advocate Christ Medical Center, Oak Lawn, Illinois 60453, United States
Starting date: October 2007
Last updated: April 8, 2012