The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

This study has been completed.
Sponsor:
Collaborator:
Emergency Medicine Foundation
Information provided by (Responsible Party):
Erik Kulstad, MD, MS, Advocate Hospital System
ClinicalTrials.gov Identifier:
NCT00441792
First received: February 27, 2007
Last updated: April 8, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Sepsis
Trauma
Drug: Etomidate
Drug: midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Etomidate Versus Midazolam for Intubation of Patients With Sepsis.

Resource links provided by NLM:


Further study details as provided by Advocate Hospital System:

Primary Outcome Measures:
  • Length of Stay [ Time Frame: time in days of hospitalization ] [ Designated as safety issue: No ]
    The primary outcome of the study was hospital length of stay.


Secondary Outcome Measures:
  • Mortality [ Time Frame: Duration of hospitalization. ] [ Designated as safety issue: No ]
    In-hospital mortality.


Enrollment: 122
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etomidate Drug: Etomidate
Etomidate at induction dose based on weight
Experimental: midazolam Drug: midazolam
Midazolam at induction dose based on weight

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441792

Locations
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Hospital System
Emergency Medicine Foundation
Investigators
Study Chair: Erik B Kulstad, MD, MS Advocate Christ Medical Center
  More Information

Publications:
Responsible Party: Erik Kulstad, MD, MS, Research Director, Advocate Hospital System
ClinicalTrials.gov Identifier: NCT00441792     History of Changes
Other Study ID Numbers: 4257
Study First Received: February 27, 2007
Results First Received: February 7, 2012
Last Updated: April 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Advocate Hospital System:
Sepsis
Etomidate
midazolam
ketamine

Additional relevant MeSH terms:
Sepsis
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
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