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Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation (Ket-RSI)

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ClinicalTrials.gov Identifier: NCT03545503
Recruitment Status : Completed
First Posted : June 4, 2018
Results First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
New Hanover Regional Medical Center
Information provided by (Responsible Party):
William F Powers, IV, MD, South East Area Health Education Center, Wilmington, NC

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE June 4, 2018
Results First Submitted Date  ICMJE September 22, 2021
Results First Posted Date  ICMJE November 26, 2021
Last Update Posted Date November 26, 2021
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2021)
Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Hemodynamic effect as measured by systolic blood pressure before and after RSI [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Official Title  ICMJE A Randomized Controlled Trial to Evaluate the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Brief Summary 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.
Detailed Description

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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intubation Complication
Intervention  ICMJE
  • Drug: Etomidate
    Etomidate will be administered as the sedative for RSI on even days
    Other Name: Amidate
  • Drug: Ketamine
    Ketamine will be administered as the sedative for RSI on odd days
    Other Name: Ketalar
Study Arms  ICMJE
  • Active Comparator: Etomidate
    Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push
    Intervention: Drug: Etomidate
  • Active Comparator: Ketamine
    Ketamine will be dosed once at a standard 2 mg/kg via IV Push
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2021)
428
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
400
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persons greater than 18yrs requiring rapid sequence intubation for any reason.

Exclusion Criteria:

  • Pregnant patients
  • Children under the age of 18
  • Patients with a known hypersensitivity to etomidate or ketamine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545503
Other Study ID Numbers  ICMJE 1712-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William F Powers, IV, MD, South East Area Health Education Center, Wilmington, NC
Study Sponsor  ICMJE South East Area Health Education Center, Wilmington, NC
Collaborators  ICMJE New Hanover Regional Medical Center
Investigators  ICMJE
Principal Investigator: William F Powers IV, MD New Hanover Regional Medical Center
PRS Account South East Area Health Education Center, Wilmington, NC
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP