Established Status Epilepticus Treatment Trial
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 1/7/2018 |
Start Date: | October 2015 |
End Date: | July 2020 |
Contact: | Jaideep Kapur, MBBS, PhD |
Email: | jk8t@virginia.edu |
Phone: | 434-924-5312 |
A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.
The primary objective is to determine the most effective and/or the least effective treatment
of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There
are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and
valproic acid (VPA).
The second objective is comparison of three drugs with respect to secondary outcomes.
The final objective is to ensure that the trial is informative for treatment of established
SE in children by describing the effectiveness, safety, and rate of adverse reactions of
these drugs in children.
of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There
are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and
valproic acid (VPA).
The second objective is comparison of three drugs with respect to secondary outcomes.
The final objective is to ensure that the trial is informative for treatment of established
SE in children by describing the effectiveness, safety, and rate of adverse reactions of
these drugs in children.
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to
treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose
of a benzo was administered in the 5-30 minutes prior to study drug administration. The
doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2
years or older
Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a
second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in
the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties
other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the
MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder;
Known liver disease; Known severe renal impairment; Known allergy or other known
contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400
mg/dL; Cardiac arrest and post-anoxic seizures
We found this trial at
65
sites
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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University of Cincinnati Medical Center Opening in 1823 as the country
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200

Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000

Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325

Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Charlottesville, Virginia 22903
(434) 924-0311

Principal Investigator: Jaideep Kapur, MBBS, PhD
Phone: 434-924-5312
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000

Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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2450 Riverside Avenue
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000

Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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