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

• 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: South East Area Health Education Center, Wilmington, NC
• 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: January 31, 2018
• First Posted Date: June 4, 2018
• Results First Submitted Date: September 22, 2021
• Results First Posted Date: November 26, 2021
• Last Update Posted Date: November 26, 2021
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Intubation Complication

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2021): 428
• Original Estimated Enrollment (submitted: May 22, 2018): 400
• Actual Study Completion Date: September 1, 2019
• Actual Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03545503
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: William F Powers, IV, MD, South East Area Health Education Center, Wilmington, NC
• Original Responsible Party: Same as current
• Current Study Sponsor: South East Area Health Education Center, Wilmington, NC
• Original Study Sponsor: Same as current
• Collaborators: New Hanover Regional Medical Center

Investigators

• 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