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| Name | Class |
|---|---|
| New Hanover Regional Medical Center | OTHER |
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The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.
This is a randomized prospective study evaluating the hemodynamic response in adult participants greater than or equal to 18 years of age undergoing RSI in the pre-hospital or emergency department setting. Hemodynamic response is the cardiology response of the circulatory system. The investigators will compare the drugs Ketamine and Etomidate in participants having RSI. Ketamine and Etomidate are immediately available for RSI in both settings as both are currently standards of care for RSI.
Research thus far demonstrates that both Etomidate and ketamine are safe and effective for RSI. Despite the reported safety of Ketamine, Etomidate usage continues to far surpass that of ketamine. Both Etomidate and Ketamine are FDA-approved for induction of anesthesia. They are both ideal drugs for intubation due to their pharmacokinetic properties including a quick onset of less than 60 seconds, a short duration of about 10 minutes, and the minimal effect they have on the cardiovascular system. The neutral effect on the cardiovascular system is particularly important in the acute and traumatic setting when patients are often hypotensive.
However, there are some differences and disadvantages in the two medications. Due to these factors and limited data to support Ketamine as an equal or superior alternative to Etomidate, it has been difficult to clearly recommend one agent over the other for RSI.
Data will be analyzed using SPSS with a p-value of less than 0.05 being considered significant. The PI will consider a 20% decrease in systolic BP from a participant baseline as significant, and will compare the incidence of post RSI hypotension between the two groups. Several a priori subgroups will be evaluated to include patients greater than 70 years of age, trauma participants requiring RSI, and those participants whose shock index is less than 0.9 versus those whose shock index is greater than 0.9.
To maintain 80% power with a probability of 0.05, 200 participants will be needed in each arm to detect at 25% difference in SBP (baseline to post drug administration effects)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etomidate | Active Comparator | Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push |
|
| Ketamine | Active Comparator | Ketamine will be dosed once at a standard 2 mg/kg via IV Push |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etomidate | Drug | Etomidate will be administered as the sedative for RSI on even days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William F Powers IV, MD | New Hanover Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
98 did not meet inclusion criteria, 48 had incomplete sedative data, and 71 were excluded for other reasons
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI | 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. | Posted | Mean | Standard Deviation | mmHg | 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. |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etomidate | Participants receiving etomidate | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTACE v.5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTACE v.5.0 | Systematic Assessment | AE for HTN grade 2 and 3 is being reported here regardless of the attribution. |
Investigators nor clinicians were blinded to study drug. Resuscitation pre-RSI was not accounted for nor was the dosing for vascopressors. We could not control the slow administration of ketamine to decrease effects of hypotension due to rapid administration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William F. Powers, IV, MD, FACS | New Hanover Regional Medical Center | 910-667-9232 | william.powers@nhrmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2017 | Sep 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine | Drug | Ketamine will be administered as the sedative for RSI on odd days |
|
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants randomized to receive ketamine
|
|
| 194 |
| 0 |
| 194 |
| 117 |
| 194 |
| EG001 | Ketamine | Participants receiving ketamine | 0 | 204 | 1 | 204 | 111 | 204 |
|
| Hypotension | Vascular disorders | CTACE v.5.0 | Systematic Assessment | AE for hypotension is being reported regardless of the grade and attribution. Note: Gr 4 is challenging to capture as participants were already being hospitalized due to their underlying condition. |
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| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |