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Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient (KLOE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04833816
Recruitment Status : Not yet recruiting
First Posted : April 6, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE April 5, 2021
First Posted Date  ICMJE April 6, 2021
Last Update Posted Date February 1, 2022
Estimated Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2021)
Total dose of sufentanil [ Time Frame: 48 hours ]
All doses of sufentanil and opiods administration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2021)
  • Total amount of opiods [ Time Frame: 5 days ]
  • Pain assessment [ Time Frame: 5 days ]
  • Delirium [ Time Frame: 5 days ]
    Scale CAM-ICU (confusion assesment method)
  • Global Quality of life [ Time Frame: 3 months ]
    SF-36 score
  • Chronical pain [ Time Frame: 3 months ]
    SF-MPQ-2
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 Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
Official Title  ICMJE Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
Brief Summary The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Injury
Intervention  ICMJE Drug: Administration of drug
Administration of ketamin during the 48h after trauma
Study Arms  ICMJE
  • Experimental: Ketamin
    Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour
    Intervention: Drug: Administration of drug
  • Placebo Comparator: Placebo
    Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour
    Intervention: Drug: Administration of drug
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2021)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female adult
  • Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface).
  • Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)> 1.
  • Patient having signed an informed consent

Exclusion Criteria:

  • Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
  • Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
  • Patient whose state of consciousness is incompatible with understanding the protocol.
  • Patient with chronic unbalanced arterial hypertension.
  • Patient with severe heart failure.
  • Patient with a BMI> 35 kg / m² or a weight of more than 120 kg.
  • Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
  • Presence of a history of chronic pain.
  • Presence of a history of epilepsy.
  • Presence of a history of psychosis or drug addiction.
  • Presence of a history of stroke.
  • Patients with an allergy to the molecule or excipients composing ketamine
  • Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
  • Pregnant or breastfeeding woman.
  • Patient not understanding French.
  • Protected adult patient (under guardianship, curatorship or legal protection).
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: Gary Duclos, MD 0491965531 ext 33 gary.duclos@ap-hm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04833816
Other Study ID Numbers  ICMJE 2019-48
2020-004812-81 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean Olivier ARNAUD AP-HM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date January 2022

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