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Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)

Primary Purpose

Status Epilepticus

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Meyer Children's Hospital IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring refractory convulsive status epilepticus, ketamine, conventional anesthetics, children

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anna Rosati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ketamine up to 100 mcg/kg/min

midazolam & thiopental & propofol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with resolution of refractory convulsive status epilepticus

Secondary Outcome Measures

Full Information

First Posted
April 3, 2015
Last Updated
October 5, 2020
Sponsor
Meyer Children's Hospital IRCCS
Collaborators
Ospedali Riuniti Ancona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02431663
Brief Title
Ketamine in Refractory Convulsive Status Epilepticus
Acronym
KETASER01
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 Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meyer Children's Hospital IRCCS
Collaborators
Ospedali Riuniti Ancona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
refractory convulsive status epilepticus, ketamine, conventional anesthetics, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine up to 100 mcg/kg/min
Arm Type
Experimental
Arm Description
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.
Arm Title
midazolam & thiopental & propofol
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
Intervention Description
Intravenous administration in continuous
Primary Outcome Measure Information:
Title
Number of participants with resolution of refractory convulsive status epilepticus
Time Frame
participant wil be followed for 24 hours after discontinuation of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Rosati, MD, PhD
Organizational Affiliation
Children's Hospital A. Meyer of Firenze, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Anna Rosati
City
Firenze
ZIP/Postal Code
50139
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30232735
Citation
Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6.
Results Reference
derived
PubMed Identifier
27311915
Citation
Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565.
Results Reference
derived

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Ketamine in Refractory Convulsive Status Epilepticus

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