NCT03115489

Brief Summary

The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

2.7 years

First QC Date

April 10, 2017

Last Update Submit

May 18, 2021

Conditions

Refractory Epilepsy

Keywords

seizureglutamate activationN-Methyl D-Aspartategamma-aminobutyric acid receptorKetamine

Outcome Measures

Primary Outcomes (2)

  • Time taken for burst suppression

    Average time for burst suppression

    Baseline to 1 hr

  • Time taken for termination of seizures

    Average time for seizures to terminate

    Baseline to 24 hrs

Secondary Outcomes (6)

  • Use of vasopressors

    baseline to 72 hrs

  • Number of days on ventilator

    Baseline to 72 hrs

  • Length of stay in ICU

    Baseline to 72 hrs postoperatively

  • Use of parenteral or enteral nutrition

    Baseline to 72 hrs postoperatively

  • Medical imaging results

    Post-op Day 2 to Post-op day 10

  • +1 more secondary outcomes

Study Arms (2)

Traditional Treatment (Group T)

PLACEBO COMPARATOR

Group T patients will be placed into burst suppression with the traditional drug infusions which include any single or combination of drugs; usually benzodiazepines, barbiturates and or propofol.

Drug: Traditional Treatment (Group T)

Ketamine Infusion (Group K)

ACTIVE COMPARATOR

Patients in the group K arm will receive a loading dose of 2.5 mg/kg of ketamine followed by a continuous infusion with a starting dose of 3mg/kg/hr with titration in 1mg/kg/hr increments until burst suppression is achieved or a maximum dose of 10mg/kg/hr is reached. After 48 hours of burst suppression the ketamine dosage will be reduced by 2mg/kg/hr in a stepwise fashion to evaluated for EEG or clinical evidence of seizure recurrence.

Drug: Ketamine Infusion (Group K)

Interventions

Traditional Treatment (Group T)DRUG

Patients will receive traditional drug infusions

Also known as: benzodiazepines, barbiturates, propofol
Traditional Treatment (Group T)
Ketamine Infusion (Group K)DRUG

Patients will receive loading dose of 2.5 mg/kg of ketamine followed by a continuous infusion with a starting dose of 3mg/kg/hr with titration in 1mg/kg/hr increments until burst suppression is achieved or a maximum dose of 10mg/kg/hr is reached

Also known as: Ketalar
Ketamine Infusion (Group K)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients more than 18 years of age with a diagnosis of status epilepticus
  • Considered for burst suppression therapy after failing 2 or 3 anti-epileptic medications

You may not qualify if:

  • Post anoxic status epilepticus
  • Pregnant women, as confirmed by urine, or blood human chorionic gonadotropin, ultrasound or physical exam
  • Prisoners
  • Age less than 18 years
  • Allergy or sensitivity to the drug in question

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

  • 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.

    PMID: 30232735DERIVED

MeSH Terms

Conditions

Drug Resistant EpilepsySeizures

Interventions

Sensitivity Training GroupsBenzodiazepinesBarbituratesPropofolKetamine

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, Alicyclic

Study Officials

  • Vinodkumar Singh, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 14, 2017

Study Start

May 4, 2017

Primary Completion

December 31, 2019

Study Completion

May 18, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)