NCT01823328

Brief Summary

The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

May 24, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

March 28, 2013

Results QC Date

August 29, 2018

Last Update Submit

May 2, 2019

Conditions

Airway ControlAnesthesiaIntubationComplication

Keywords

IntubationAirwayEmergent intubationRapid sequence intubationRapid sequence inductionRSIKetamineEtomidateSepsisSedativeSedation

Outcome Measures

Primary Outcomes (1)

  • SOFA Score

    \*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.

    up to 3 days

Secondary Outcomes (7)

  • Mortality in Sepsis and Septic Shock

    30 Days

  • Number of Patients With First-pass Success

    up to 5 minutes (average time frame)

  • Doses of Post-intubation Sedation

    up to 6 hours

  • Number of Patients With Post-intubation Hypoxemia

    up to 2 hours

  • Number of Patients With Hypotension

    up to 6 hours

  • +2 more secondary outcomes

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).

Drug: Ketamine

Etomidate

ACTIVE COMPARATOR

Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).

Drug: Etomidate

Interventions

KetamineDRUG

Subjects will receive ketamine for sedation prior to rapid sequence intubation.

Also known as: Ketanest, Ketaset, Ketalar
Ketamine
EtomidateDRUG

Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Also known as: Amidate
Etomidate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

KetamineEtomidate

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Audrey Hendrickson
Organization
Hennepin Healthcare
Audrey.Hendrickson@hcmed.org
612-873-9528

Study Officials

  • Brian E Driver, MD

    Hennepin County Medical Canter

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 4, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 24, 2019

Results First Posted

May 24, 2019

Record last verified: 2019-05

Locations

US(1)