Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)

Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.

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.

Study Overview

• Status: Terminated
• Conditions: Status Epilepticus
• Intervention / Treatment: Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy, 50139
    • Anna Rosati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with resolution of refractory convulsive status epilepticus	participant wil be followed for 24 hours after discontinuation of study drug

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Azienda Ospedaliera Universitaria Integrata Verona; Catholic University of the Sacred Heart; University of Padova; Bambino Gesù Hospital and Research Institute; IRCCS Burlo Garofolo; Ospedali Riuniti Ancona; Nuovo Regina Margherita Hospital; Vittore Buzzi Children's Hospital
• Investigators: Study Chair: Anna Rosati, MD, PhD, Children's Hospital A. Meyer of Firenze, Italy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: children; ketamine; refractory convulsive status epilepticus; conventional anesthetics
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: EudraCT number: 2013-004396-12