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Ketamine Versus Etomidate for Rapid Sequence Intubation

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ClinicalTrials.gov Identifier: NCT01823328
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Tracking Information
First Submitted Date  ICMJE March 28, 2013
First Posted Date  ICMJE April 4, 2013
Results First Submitted Date  ICMJE August 29, 2018
Results First Posted Date  ICMJE May 24, 2019
Last Update Posted Date May 24, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
SOFA Score [ Time Frame: up to 3 days ]
*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
Mortality [ Time Frame: 30 Days or Discharge ]
Compare mortality 30 days after enrollment between the two treatment groups
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Mortality in Sepsis and Septic Shock [ Time Frame: 30 Days ]
    Evaluate mortality for the sub-group diagnosed with sepsis and septic shock, defined as: - Suspected infection, and at least 2 of 4 systemic inflammatory response syndrome (SIRS) criteria:
    1. Temperature >38C or <36C
    2. Respiratory Rate >20 or PaCO2 <32 mmHg
    3. Heart Rate >90
    4. White blood cell count >12,000 or <4,000, or > 10% bands
    Septic shock: defined as sepsis plus either: 1) Systolic blood pressure <90 after 1L of intravenous fluid or 2) lactate >=4mmol/L
  • Number of Patients With First-pass Success [ Time Frame: up to 5 minutes (average time frame) ]
    The rate of first pass success, defined as successful tracheal intubation on the first attempt. An attempt is defined as the insertion and subsequent removal of the laryngoscopic device from the patient's mouth, regardless of whether an endotracheal tube was inserted.
  • Doses of Post-intubation Sedation [ Time Frame: up to 6 hours ]
    The number of bolus doses of sedative administered post-intubation will be compared up to 6 hours (including morphine, dexmedetomidine, propofol , etomidate, ketamine, lorazepam (Ativan), midazolam (Versed), diazepam (Valium), fentanyl, hydromorphone (Dilaudid)). Infusions of these medications will be recorded separately but will not be part of this outcome.
  • Number of Patients With Post-intubation Hypoxemia [ Time Frame: up to 2 hours ]
    The following will be compared between the two groups:
    • Hypoxemia and severe hypoxemia in the peri-intubation period. Peri-intubation hypoxemia was defined as during after the 5 minutes immediately after intubation.
    • Hypoxemia within the first 2 hours intubation
    Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more.
  • Number of Patients With Hypotension [ Time Frame: up to 6 hours ]
    The following will be compared between the two groups:
    • Hypotension in the ED post-intubation
    • Hypotension within the first 6 hours of the hospital stay, including time spent in the ED
    Hypotension is defined as a systolic blood pressure less than 90 mm Hg
  • Peak and Plateau Pressure [ Time Frame: up to 30 minutes (average time frame) ]
    The Peak and plateau pressures will be compared between the two groups, with a pre-defined subgroup analysis of patients who are being intubated for severe asthma and chronic obstructive pulmonary disease (COPD). The ventilator was used to measure these values.
  • Mortality [ Time Frame: 30 Days or Discharge ]
    Mortality will be assessed at 30 days or at discharge from the hospital, whichever occurs first. This study is not powered to detect a significant difference in mortality, however; this will primarily be a safety study comparing the use ketamine versus etomidate as sedative agents for rapid sequence intubation (RSI) in the Emergency Department (ED).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2013)
  • Sepsis [ Time Frame: 30 Days ]
    Evaluate mortality for the sub-group diagnosed with sepsis, defined as: - Suspected infection, and at least 2 of 4 systemic inflammatory response syndrome (SIRS) criteria:
    1. Temperature >38C or <36C
    2. Respiratory Rate >20 or PaCO2 <32 mmHg
    3. Heart Rate >90
    4. WBC >12,000 or <4,000, or > 10% bands
  • Septic Shock [ Time Frame: 30 Days or Discharge ]
    Evaluate mortality of the sub-group diagnosed with septic shock, as defined as sepsis plus either:
    • Systolic blood pressure <90 mmHg after 1L of intravenous fluid; or
    • Lactate >= 4 mmol/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Etomidate for Rapid Sequence Intubation
Official Title  ICMJE Ketamine Versus Etomidate for Sedation of Emergency Department Patients During Rapid Sequence Intubation
Brief Summary The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).
Detailed Description This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.
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
  • Airway Control
  • Anesthesia
  • Intubation
  • Complication
Intervention  ICMJE
  • Drug: Ketamine
    Subjects will receive ketamine for sedation prior to rapid sequence intubation.
    Other Names:
    • Ketanest
    • Ketaset
    • Ketalar
  • Drug: Etomidate
    Subjects will receive etomidate for sedation prior to rapid sequence intubation.
    Other Name: Amidate
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).
    Intervention: Drug: Ketamine
  • Active Comparator: Etomidate
    Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).
    Intervention: Drug: Etomidate
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: May 2, 2019)
143
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2013)
800
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age
  • Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria:

  • Known contraindication to ketamine or etomidate
  • Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
  • Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
  • Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
  • Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
  • Prisoner
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 NCT01823328
Other Study ID Numbers  ICMJE HSR 13-3601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hennepin Healthcare Research Institute
Study Sponsor  ICMJE Hennepin Healthcare Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian E Driver, MD Hennepin County Medical Canter
PRS Account Hennepin Healthcare Research Institute
Verification Date May 2019

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