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The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

Primary Purpose

Sepsis, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Etomidate
midazolam
Sponsored by
Advocate Hospital System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Etomidate, midazolam, ketamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advocate Christ Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Etomidate

midazolam

Arm Description

Outcomes

Primary Outcome Measures

Length of Stay
The primary outcome of the study was hospital length of stay.

Secondary Outcome Measures

Mortality
In-hospital mortality.

Full Information

First Posted
February 27, 2007
Last Updated
April 8, 2012
Sponsor
Advocate Hospital System
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00441792
Brief Title
The Effect of Etomidate on Patient Outcomes After Single Bolus Doses
Official Title
A Randomized Trial of Etomidate Versus Midazolam for Intubation of Patients With Sepsis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Hospital System
Collaborators
Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Trauma
Keywords
Sepsis, Etomidate, midazolam, ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Experimental
Arm Title
midazolam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Etomidate
Intervention Description
Etomidate at induction dose based on weight
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
Midazolam at induction dose based on weight
Primary Outcome Measure Information:
Title
Length of Stay
Description
The primary outcome of the study was hospital length of stay.
Time Frame
time in days of hospitalization
Secondary Outcome Measure Information:
Title
Mortality
Description
In-hospital mortality.
Time Frame
Duration of hospitalization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik B Kulstad, MD, MS
Organizational Affiliation
advocate christ medical center
Official's Role
Study Chair
Facility Information:
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20828877
Citation
Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med. 2010 Nov;56(5):481-9. doi: 10.1016/j.annemergmed.2010.05.034. Epub 2010 Sep 15.
Results Reference
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The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

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