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Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity (KETASED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00440102
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 23, 2007
First Posted Date  ICMJE February 26, 2007
Last Update Posted Date September 22, 2011
Study Start Date  ICMJE April 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA) [ Time Frame: at the end of D2 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2007)
  • Maximal value of the "Sepsis-related Organ Failure"
  • SOFA in the first 48 hours of hospitalization.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
  • Mortality, length of stay in the intensive care unit and in the hospital, length of stay under artificial ventilation, neurological state at the exit of the hospital and adverse effects : within the first 28 days. [ Time Frame: at D0 ]
  • intubation difficulty [ Time Frame: at D0 ]
  • early complications [ Time Frame: at D0 ]
  • adverse effects [ Time Frame: at D0 ]
  • SOFA in the first 48 hours of hospitalization [ Time Frame: at the ende of D2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2007)
  • Mortality, length of stay in the intensive care unit and in the hospital, length of stay under artificial ventilation, neurological state at the exit of the hospital,
  • intubation difficulty,
  • early complications,
  • adverse effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Official Title  ICMJE Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Brief Summary The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.
Detailed Description

The national recommendations of sedation concerning the intubation in emergency settings advise the use of a hypnotic, etomidate associated to succinylcholine. A national inquiry showed that more than 80% of prehospital intubations use a rapid sequence intubation as sedation. However, several recent studies throw into question the use of etomidate in this indication. Indeed, etomidate is a powerful inhibitor of the synthesis of cortisol. Adrenocortical hormone insufficiency is clearly associated to an increase in the morbidity-mortality of critically ill patients. Several authors advise therefore against the use of etomidate for such patients. Yet, to date, only indirect arguments associating the use of etomidate with excessive morbidity-mortality exist. A real causality link is not yet established. Another hypnotic that could constitute a therapeutic alternative to the use of etomidate exists: ketamine. The advantage of this molecule is that it does not inhibit the adrenocortical hormone axis.

Objectives: To evaluate sedation using ketamine versus etomidate in term of morbidity-mortality in critically ill patients intubated in the prehospital setting.

Experimental diagram: A prospective, multicentric, randomized, controlled, simple blind trial with independent analysis of the primary outcome.

The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation. The risks incurred for patients being suitable to this research are bound essentially to the adverse effects of ketamine. These include some psycho-dyslectic manifestations: nightmare, unpleasant awakening, and disruption of the visual, auditory sensations and mood, a sensation to float and sometimes depersonalization. These adverse effects are warned by a continuous administration of benzodiazepines.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Intubation; Difficult
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine
  • Drug: Etomidate
    Etomidate
Study Arms  ICMJE
  • Active Comparator: 1
    ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: 2
    Etomidate
    Intervention: Drug: Etomidate
Publications *

*   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: September 8, 2008)
655
Original Enrollment  ICMJE
 (submitted: February 23, 2007)
250
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient requiring sedation for prehospital endotracheal intubation
  • Age ≥ 18 years
  • Consent of a family member if present, then of the patient for the pursuit of research

Exclusion Criteria:

  • Patient in cardiac arrest
  • Presence of contraindication to succinylcholine:

    • Personal or familial history of malignant hyperthermia
    • Known hypersensitivity to succinylcholine
    • Skeletal muscle disease
    • Myasthenia
    • Known hyperkalemia
    • Severe ophthalmic injury
    • Known congenital deficit in plasmatic pseudo-cholinesterase
  • Presence of contraindication to ketamine:

    • Known hypersensitivity to ketamine
    • Known porphyria
    • Severe hypertension
  • Presence of contraindication to etomidate:

    • Known untreated adrenal insufficiency
    • Known hypersensitivity to etomidate
  • Known pregnancy
  • Unaffiliated patient to the social insurance
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00440102
Other Study ID Numbers  ICMJE P060213
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederic ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2007

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