The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

NCT ID: NCT00441792

Last Updated: 2012-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-12-31

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.

Conditions

Sepsis; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Etomidate

Group Type: EXPERIMENTAL

Etomidate

Intervention Type: DRUG

Etomidate at induction dose based on weight

midazolam

Group Type: EXPERIMENTAL

midazolam

Intervention Type: DRUG

Midazolam at induction dose based on weight

Interventions

Etomidate

Etomidate at induction dose based on weight

Intervention Type: DRUG

midazolam

Midazolam at induction dose based on weight

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emergency Medicine Foundation

OTHER

Sponsor Role: collaborator

Advocate Hospital System

OTHER

Sponsor Role: lead

Responsible Party

Erik Kulstad, MD, MS

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik B Kulstad, MD, MS

Role: STUDY_CHAIR

advocate christ medical center

Locations

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20828877 (View on PubMed)

Other Identifiers

4257

Identifier Type: -

Identifier Source: org_study_id