The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

April 8, 2012 updated by: Erik Kulstad, MD, MS, Advocate Hospital System

A Randomized Trial of Etomidate Versus Midazolam for Intubation of Patients With Sepsis.

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.

Research Hypothesis:

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 patient management.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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% bands).
  • 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.

Exclusion Criteria:

  • An age less than 18
  • Pregnancy
  • Do-not-resuscitate status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etomidate
Drug: Etomidate
Etomidate at induction dose based on weight
Experimental: midazolam
Drug: midazolam
Midazolam at induction dose based on weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: time in days of hospitalization
The primary outcome of the study was hospital length of stay.
time in days of hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Duration of hospitalization.
In-hospital mortality.
Duration of hospitalization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Hospital System

Collaborators

Emergency Medicine Foundation

Investigators

  • Study Chair: Erik B Kulstad, MD, MS, Advocate Christ Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 8, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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