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Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)

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: NCT02431663
Recruitment Status : Recruiting
First Posted : May 1, 2015
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Ospedali Riuniti Ancona
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
University of Padova
Bambino Gesù Hospital and Research Institute
Catholic University of the Sacred Heart
IRCCS Burlo Garofolo
Azienda Ospedaliera Universitaria Integrata Verona
Nuovo Regina Margherita Hospital
Vittore Buzzi Children's Hospital
Information provided by (Responsible Party):
Anna Rosati, Meyer Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE May 1, 2015
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
Number of participants with resolution of refractory convulsive status epilepticus [ Time Frame: participant wil be followed for 24 hours after discontinuation of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine in Refractory Convulsive Status Epilepticus
Official Title  ICMJE Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
Brief Summary To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Status Epilepticus
Intervention  ICMJE Drug: Ketamine
Intravenous administration in continuous
Other Name: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
Study Arms  ICMJE
  • Experimental: ketamine up to 100 mcg/kg/min
    Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days.
    Intervention: Drug: Ketamine
  • Active Comparator: midazolam & thiopental & propofol

    Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h.

    Maximum duration of infusion for each drug will be 48 hours.

    Intervention: Drug: Ketamine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2015)
57
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
  • Refractoriness of the drug I and II line
  • Written informed consent from parents or legal guardian.
  • Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.

Exclusion Criteria:

  • contraindications to the use of the medication/s in the study.
  • pregnant or suspected pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Rosati, MD, PhD 0555662573 ext 0039 a.rosati@meyer.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02431663
Other Study ID Numbers  ICMJE EudraCT number: 2013-004396-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Rosati, Meyer Children's Hospital
Study Sponsor  ICMJE Meyer Children's Hospital
Collaborators  ICMJE
  • Ospedali Riuniti Ancona
  • Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  • University of Padova
  • Bambino Gesù Hospital and Research Institute
  • Catholic University of the Sacred Heart
  • IRCCS Burlo Garofolo
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Nuovo Regina Margherita Hospital
  • Vittore Buzzi Children's Hospital
Investigators  ICMJE
Study Chair: Anna Rosati, MD, PhD Children's Hospital A. Meyer of Firenze, Italy
PRS Account Meyer Children's Hospital
Verification Date June 2018

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