Trial Outcomes & Findings for The Effect of Etomidate on Patient Outcomes After Single Bolus Doses (NCT NCT00441792)

NCT ID: NCT00441792

Last Updated: 2012-04-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: time in days of hospitalization
• Results posted on: 2012-04-11

Participant Flow

Patients eligible for this study were enrolled from November 2007 until May 2009. Patients were eligible if they were older than 18 years, were intubated in the ED, and had a suspected infectious cause for their illness.

Participant milestones

Measure	Midazolam Patients received either etomidate or midazolam.	Etomidate Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
Overall Study STARTED	59	63
Overall Study COMPLETED	59	61
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Midazolam Patients received either etomidate or midazolam.	Etomidate Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

The Effect of Etomidate on Patient Outcomes After Single Bolus Doses

Baseline characteristics by cohort

Measure	Midazolam n=59 Participants Patients received either etomidate or midazolam.	Etomidate n=63 Participants Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.	Total n=122 Participants Total of all reporting groups
Age, Customized	73 years n=93 Participants	70 years n=4 Participants	72 years n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	30 Participants n=4 Participants	53 Participants n=27 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	33 Participants n=4 Participants	69 Participants n=27 Participants

PRIMARY outcome

Timeframe: time in days of hospitalization

Population: All patients entering into the study were analyzed on an intent to treat basis.

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

Outcome measures

Measure	Midazolam n=59 Participants Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.	Etomidate n=61 Participants Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
Length of Stay	9.5 days Interval 4.6 to 16.0	7.3 days Interval 3.1 to 13.0

SECONDARY outcome

Timeframe: Duration of hospitalization.

Population: All patients entering into the study were analyzed on an intent to treat basis.

In-hospital mortality.

Outcome measures

Measure	Midazolam n=59 Participants Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.	Etomidate n=61 Participants Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
Mortality	36 percentage of patients dying Interval 24.0 to 49.0	43 percentage of patients dying Interval 30.0 to 56.0

Adverse Events

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etomidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erik Kulstad, MD, MS

Advocate Christ Medical Center

Phone: 7086843889

Email: kulstad@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place