Trial Outcomes & Findings for Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation (NCT NCT03545503)

Results Overview

The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

428 participants

Primary outcome timeframe

The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.

Results posted on

2021-11-26

Participant Flow

Participants were recruited if they required rapid sequence intubation in the pre-hospital or 17th street campus emergency department setting between January 1, 2018 and July 30, 2019.

98 did not meet inclusion criteria, 48 had incomplete sedative data, and 71 were excluded for other reasons

Participant milestones

Participant milestones
Measure	Etomidate Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push Etomidate: Etomidate will be administered as the sedative for RSI on even days	Ketamine Ketamine will be dosed once at a standard 2 mg/kg via IV Push Ketamine: Ketamine will be administered as the sedative for RSI on odd days
Overall Study STARTED	208	220
Overall Study COMPLETED	194	204
Overall Study NOT COMPLETED	14	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Etomidate Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push Etomidate: Etomidate will be administered as the sedative for RSI on even days	Ketamine Ketamine will be dosed once at a standard 2 mg/kg via IV Push Ketamine: Ketamine will be administered as the sedative for RSI on odd days
Overall Study Protocol Violation	14	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etomidate n=194 Participants Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push Etomidate: Etomidate will be administered as the sedative for RSI on even days	Ketamine n=204 Participants Ketamine will be dosed once at a standard 2 mg/kg via IV Push Ketamine: Ketamine will be administered as the sedative for RSI on odd days	Total n=398 Participants Total of all reporting groups
Age, Continuous	57.48 years STANDARD_DEVIATION 19.5 • n=194 Participants	56.68 years STANDARD_DEVIATION 19.68 • n=204 Participants	57.08 years STANDARD_DEVIATION 19.57 • n=398 Participants
Sex: Female, Male Female	67 Participants n=194 Participants	74 Participants n=204 Participants	141 Participants n=398 Participants
Sex: Female, Male Male	127 Participants n=194 Participants	130 Participants n=204 Participants	257 Participants n=398 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.

The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.

Outcome measures

Outcome measures
Measure	Etomidate n=194 Participants Participants randomized to receive etomidate	Ketamine n=204 Participants Participants randomized to receive ketamine
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI Pre-SBP	138.04 mmHg Standard Deviation 38.63	132.39 mmHg Standard Deviation 39.54
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI Post SBP 0-7	139.09 mmHg Standard Deviation 44.52	130.09 mmHg Standard Deviation 41.78
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI Post SBP 8-15	130.42 mmHg Standard Deviation 42.19	120.80 mmHg Standard Deviation 37.37

Adverse Events

Etomidate

Serious events: 0 serious events

Other events: 117 other events

Deaths: 0 deaths

Ketamine

Serious events: 1 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etomidate n=194 participants at risk Participants receiving etomidate	Ketamine n=204 participants at risk Participants receiving ketamine
Vascular disorders Hypertension	0.00% 0/194 • 24 hours	0.49% 1/204 • 24 hours

Other adverse events

Other adverse events
Measure	Etomidate n=194 participants at risk Participants receiving etomidate	Ketamine n=204 participants at risk Participants receiving ketamine
Vascular disorders Hypertension	60.3% 117/194 • 24 hours	54.4% 111/204 • 24 hours
Vascular disorders Hypotension	18.6% 36/194 • 24 hours	26.0% 53/204 • 24 hours

Additional Information

William F. Powers, IV, MD, FACS

New Hanover Regional Medical Center

Phone: 910-667-9232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place