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Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus

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: NCT03115489
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Vinodkumar Singh, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Drug: Traditional Treatment (Group T) Drug: Ketamine Infusion (Group K) Phase 2 Phase 3

Detailed Description:

The traditional treatment for refractory status epilepticus includes diazepam, midazolam, valproic acid, thiopental and propofol. These medications fail to control seizure activity in 20-40% of patients. This is attributed to decrease in activity of gamma-aminobutyric acid receptors along with reciprocal up regulation of N-Methyl-D-aspartate receptors. Glutamate activation of N-methyl-D-aspartate receptors promotes calcium influx and excitotoxicity. Ketamine, an intravenous anesthetic agent which is a non-competitive antagonist of N-methyl-D-aspartate receptors can block the flow of Ca and Na and by combining with phencyclidine binding sites inside the ion channel of N-methyl-D-aspartate receptors, reduce the epileptiform burst discharges and after potential. Therefore, targeting the N-methyl-D-aspartate receptors with ketamine may provide a novel approach to control refractory seizures. Moreover, by blocking glutamate mediated N-methyl-D-aspartate receptor induced neurotoxicity, ketamine may render neuroprotection. Ketamine also provides additional advantage of hemodynamic stability. Currently, ketamine is used as a last resort drug in the treatment of refractory status epilepticus.

The specific aim is to determine whether continuous infusion of ketamine as a first line agent for refractory status epilepticus is effective in controlling seizures.

The central hypothesis of our proposal is that early treatment with ketamine will be much more efficacious in controlling refractory status compared to the traditional treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus- a Pilot Study
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Traditional Treatment (Group T)
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)
Patients will receive traditional drug infusions
Other Name: benzodiazepines, barbiturates, propofol

Active Comparator: Ketamine Infusion (Group K)
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)
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
Other Name: Ketalar




Primary Outcome Measures :
  1. Time taken for burst suppression [ Time Frame: Baseline to 1 hr ]
    Average time for burst suppression

  2. Time taken for termination of seizures [ Time Frame: Baseline to 24 hrs ]
    Average time for seizures to terminate


Secondary Outcome Measures :
  1. Use of vasopressors [ Time Frame: baseline to 72 hrs ]
    The need of vasopressors

  2. Number of days on ventilator [ Time Frame: Baseline to 72 hrs ]
    Total number of days patient is on the ventilator

  3. Length of stay in ICU [ Time Frame: Baseline to 72 hrs postoperatively ]
    Total number of days in the ICU

  4. Use of parenteral or enteral nutrition [ Time Frame: Baseline to 72 hrs postoperatively ]
    Nutrition provided through a feeding tube or catheter

  5. Medical imaging results [ Time Frame: Post-op Day 2 to Post-op day 10 ]
    MRI scans 7 to 10 days after burst suppression

  6. Mortality [ Time Frame: baseline to post-op day 10 ]
    death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03115489


Contacts
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Contact: Adam Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu
Contact: Ayesha Bryant, MD 205-996-7383 asbryant@uabmc.edu

Locations
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United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine Recruiting
Birmingham, Alabama, United States, 35249
Contact: Adam Sturdivant, MPH    205-934-4042    adamsturdivant@uabmc.edu   
Contact: Ayesha Bryant, MSPH, MD    205-996-7383    asbryant@uabmc.edu   
Principal Investigator: Vinodkumar Singh, MD         
Sub-Investigator: Angela Douglas, MD         
Sub-Investigator: Casey May, PharmD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Vinodkumar Singh, MD University of Alabama at Birmingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vinodkumar Singh, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03115489    
Other Study ID Numbers: F151214004
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Vinodkumar Singh, University of Alabama at Birmingham:
seizure
glutamate activation
N-Methyl D-Aspartate
gamma-aminobutyric acid receptor
Ketamine
Additional relevant MeSH terms:
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Status Epilepticus
Drug Resistant Epilepsy
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Seizures
Neurologic Manifestations
Signs and Symptoms
Ketamine
Propofol
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action