Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02431663
Previous Study | Return to List | Next Study

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

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.

Condition or disease Intervention/treatment Phase
Status Epilepticus Drug: Ketamine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
Drug: Ketamine
Intravenous administration in continuous
Other Name: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)

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.

Drug: Ketamine
Intravenous administration in continuous
Other Name: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)




Primary Outcome Measures :
  1. Number of participants with resolution of refractory convulsive status epilepticus [ Time Frame: participant wil be followed for 24 hours after discontinuation of study drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431663


Contacts
Layout table for location contacts
Contact: Anna Rosati, MD, PhD 0555662573 ext 0039 a.rosati@meyer.it

Locations
Layout table for location information
Italy
Anna Rosati Recruiting
Firenze, Italy, 50139
Contact: Anna Rosati, MD, PhD    0555662573 ext 0039    a.rosati@meyer.it   
Sponsors and Collaborators
Meyer Children's Hospital
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
Layout table for investigator information
Study Chair: Anna Rosati, MD, PhD Children's Hospital A. Meyer of Firenze, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Anna Rosati, MD, PhD, Meyer Children's Hospital
ClinicalTrials.gov Identifier: NCT02431663     History of Changes
Other Study ID Numbers: EudraCT number: 2013-004396-12
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Keywords provided by Anna Rosati, Meyer Children's Hospital:
refractory convulsive status epilepticus
ketamine
conventional anesthetics
children

Additional relevant MeSH terms:
Layout table for MeSH terms
Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Thiopental
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Hypnotics and Sedatives
GABA Modulators
GABA Agents