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Use of Ketamine Associate With an Opioid for Sedation in ICU (KetaRea)

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: NCT01560390
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE November 17, 2011
First Posted Date  ICMJE March 22, 2012
Last Update Posted Date January 14, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
Amount of opiate used between study enrollment and mechanical ventilation withdrawal. [ Time Frame: after 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • Confusion Duration assessed by CAM-ICU [ Time Frame: after 24 hours ]
  • mechanical ventilation duration [ Time Frame: after 24 hours ]
  • ICU length of stay [ Time Frame: after 24 hours ]
  • Mortality at D28 [ Time Frame: at day 28 ]
  • hyperalgesia during sedation [ Time Frame: after 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Ketamine Associate With an Opioid for Sedation in ICU
Official Title  ICMJE Use of Ketamine Associate With an Opioid for Sedation in ICU : a Randomized Controlled Double Blind Study
Brief Summary The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Detailed Description All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Sedation for Mechanical Ventilation
Intervention  ICMJE
  • Drug: Rémifentamil + KETAMINE
    All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
  • Drug: ketamine
    to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Study Arms  ICMJE
  • Rémifentanil + Kétamine
    to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
    Interventions:
    • Drug: Rémifentamil + KETAMINE
    • Drug: ketamine
  • Rémifentanil + Placebo
    to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
    Interventions:
    • Drug: Rémifentamil + KETAMINE
    • 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: March 20, 2012)
164
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all patients under mechanical ventilation

Exclusion Criteria:

  • pregnant
  • psychotic
  • chronic use of opiates
  • age < 18 years
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 NCT01560390
Other Study ID Numbers  ICMJE CHU-0108
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Clermont-Ferrand
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date January 2013

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