The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

NCT00441792 | Completed Results

• 1 other identifier: 4257
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Trauma

Keywords

Sepsis; Etomidate; midazolam; ketamine

Outcome Measures

Primary Outcomes (1)

• Length of Stay

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

  time in days of hospitalization

Secondary Outcomes (1)

• Mortality

  Duration of hospitalization.

Study Arms (2)

Etomidate

EXPERIMENTAL

Drug: Etomidate

midazolam

EXPERIMENTAL

Drug: midazolam

Interventions

Etomidate DRUG

Etomidate at induction dose based on weight

Etomidate

midazolam DRUG

Midazolam at induction dose based on weight

midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Advocate Hospital System: lead
• Emergency Medicine Foundation: collaborator

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (1)

• 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.

  PMID: 20828877 RESULT

MeSH Terms

Conditions

Sepsis; Wounds and Injuries

Interventions

Etomidate; Midazolam

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Because of limitations in the availability of study investigators and pharmacists, we were unable to enroll all potentially eligible patients, raising the possibility that our study sample was not representative of our entire patient population.

Results Point of Contact

• Title: Erik Kulstad, MD, MS
• Organization: Advocate Christ Medical Center

kulstad@uic.edu

7086843889

Study Officials

• Erik B Kulstad, MD, MS

  advocate christ medical center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 11, 2012
• Results First Posted: April 6, 2012

Record last verified: 2012-04

Locations

US (1)