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Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications (RAMPART)
This study is currently recruiting participants.
Verified by University of Michigan, September 2009
First Received: December 15, 2008   Last Updated: January 27, 2010   History of Changes
Sponsor: University of Michigan
Collaborators: Medical University of South Carolina
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: University of Michigan
ClinicalTrials.gov Identifier: NCT00809146
  Purpose

The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.


Condition Intervention Phase
Status Epilepticus
Other: Intramuscular route of active treatment
Other: Intravenous route of active treatment
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The binary outcome variable measuring whether or not there is termination of convulsive seizure activity prior to ED arrival after an initial dose of study medication without the need for a second rescue dose of benzodiazepine by EMS [ Time Frame: Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Times from EMS arrival to convulsive seizure termination & from treatment initiation to seizure termination, frequency of endotracheal intubation, frequency & duration of hospitalization & ICU admission, & frequency of acute seizure recurrence. [ Time Frame: All time interval outcomes are measured during prehospital care on the day of enrollment, other secondary outcomes are determined on the day of enrollment, at 24 hours, and at hospital discharge or on hospital day 90. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intramuscular (IM) anticonvulsant: Active Comparator
This group gets active treatment with an anticonvulsant by the intramuscular route of administration.
Other: Intramuscular route of active treatment
IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
Intravenous (IV) anticonvulsant: Active Comparator
This group gets active treatment with an anticonvulsant by the intravenous route of administration.
Other: Intravenous route of active treatment
IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.

Detailed Description:

Seizures are a common medical problem. Although they can be frightening to watch, most seizures are brief and stop by themselves. Seizures that don't stop in seconds or minutes are a dangerous life-threatening medical emergency. Paramedics often have medications that can stop seizures, but the best way to give the medicines is not known. Paramedics often give medicine directly into a vein, which is called intravenous (IV) administration. This works well, but can be hard to do in a person who is seizing. It can also take some time and delay treatment. Another way to give the medicine is as a shot given into a muscle, which is called intramuscular (IM) administration. Giving the medicine this way is faster, but it may not stop the seizure as quickly.

This clinical trial is designed to figure out whether giving anti-seizure medicine works similarly well and more quickly when given through an IV or when given as a shot in the muscle. Two similar medicines will be used. Both are already used by paramedics in the field and by doctors in the hospital to stop seizures. One is commonly given by IV, and the other is commonly given as a shot in the muscle. In this study, the shot will be given using a device similar to an EpiPen—which is an autoinjector used by people with severe allergies.

Approximately 800 persons whose seizures are continuing after emergency medical service (EMS) arrival and who meet all eligibility criteria will be enrolled in the trial. Every participant will be treated with anti-seizure medicine by the paramedics. At random, half the participants will be in one group and half in another. Half the participants will receive the study medicine through an IV and will be given a shot in the muscle without medicine (placebo). The other half will receive the medicine as a shot in the muscle plus an IV without medicine (placebo).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paramedics or reliable witnesses verify 5 minutes of either continuous seizure activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
  • Patient is still seizing at the time of paramedic treatment with study medications.
  • Estimated weight equal to or greater than 13 kg.
  • Subject to be transported to a RAMPART participating hospital.

Exclusion Criteria:

  • Major trauma as the precipitant of the seizure
  • Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)
  • Known allergy to midazolam or lorazepam
  • Cardiac arrest or heart rate (HR) <40 beats per minute
  • Sensitivity to benzodiazepines
  • Medical alert tag marked with "RAMPART declined"
  • Prior treatment of this seizure with diazepam autoinjector as part of another study
  • Known pregnancy
  • Prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809146

Contacts
Contact: Robert Silbergleit, MD 724-232-2142 robie@umich.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85742
Contact: Kurt Denninghoff, MD     520-626-1551     kdenninghoff@aemrc.arizona.edu    
Contact: Bruce Barnhart         BBarnhart@aemrc.arizona.edu    
Principal Investigator: Kurt Denninghoff, MD            
Sub-Investigator: Daniel Spaite, MD            
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304-5777
Contact: James Quinn, MD     650-736-4391     jquinn@stanfordmed.org    
Contact: Stephanie Casal         scasal@stanford.edu    
Principal Investigator: James V Quinn, MD            
University of California-San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Claude Hemphill, MD     415-206-3213     chemphill@sfgh.ucsf.edu    
Contact: Michele Meeker, RN         meekerm@neurosurg.ucsf.edu    
Principal Investigator: Claude Hemphill, MD            
Sub-Investigator: Karl Sporer, MD            
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: David Wright, MD     404-778-1709     David.Wright@Emory.edu    
Contact: Harriet Howlett-Smith, RN         hhowlet@emory.edu    
Principal Investigator: David Wright, MD            
Sub-Investigator: Bittner Matthew, MD            
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0298
Contact: Roger Humphries, MD     859-323-5908     rlhump0@uky.edu    
Contact: Christofer Sweat         sweatclfd@gmail.com    
Principal Investigator: Roger Humphries, MD            
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert Welch, MD     313-993-2534     rwelch@med.wayne.edu    
Contact: LynnMarie Mango         lmmango@med.wayne.edu    
Principal Investigator: Robert Welch, MD            
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Christopher Lewandowski, MD     313-916-1553     clewand1@hfhs.org    
Contact: Paula Crouse         PCROUSE1@hfhs.org    
Principal Investigator: Christopher Lewandowski, MD            
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Michelle Biros, MD     612-873-7586     michelle.biros@gmail.com    
Contact: Corey Sargent         sarge022@umn.edu    
Principal Investigator: Michelle H Biros, MD            
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Arthur Pancioli, MD     513-558-8103     pancioam@ucmail.uc.edu    
Contact: Irene Ewing, RN         irene.ewing@uc.edu    
Principal Investigator: Arthur Pancioli, MD            
Sub-Investigator: Jason McMullan, MD            
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Robert Lowe, MD     503-494-7551     lowero@ohsu.edu    
Contact: Rachel Stone         stonera@ohsu.edu    
Principal Investigator: Robert Lowe, MD            
Sub-Investigator: Craig Warden, MD            
United States, Pennsylvania
University of Pennsylvania/York Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jill Baren, MD     215-662-6917     barenj@uphs.upenn.edu    
Contact: Katie Lamond         Katherine.Lamond@uphs.upenn.edu    
Principal Investigator: Jill Baren, MD            
Sub-Investigator: R. Daniel Bledsoe, MD            
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD         ngentile@temple.edu    
Contact: Christopher Vates         cvates@temple.edu    
Principal Investigator: Nina Gentile, MD            
United States, Texas
University of Texas-Houston Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Jones, MD     713-500-7864     Elizabeth.B.Jones@uth.tmc.edu    
Contact: Misty Ottman         misty.ottman@uth.tmc.edu    
Principal Investigator: Elizabeth Jones, MD            
Sub-Investigator: Bonnie Richter, MD            
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Joseph Ornato, MD     804-828-7184     jpornato@vcu.edu    
Contact: Michael Kurz         mkurz@mcvh-vcu.edu    
Principal Investigator: Joseph P Ornato, MD            
Sub-Investigator: Michael Kurz, MD            
Sponsors and Collaborators
University of Michigan
Medical University of South Carolina
University of California, San Francisco
Investigators
Principal Investigator: Robert Silbergleit, MD University of Michigan
Principal Investigator: Daniel H Lowenstein, MD University of California, San Francisco
Principal Investigator: Valerie L Durkalski, PhD Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: University of Michigan ( Robert Silbergleit, MD, Principal Investigator )
Study ID Numbers: R01NS053031, 5U01NS056975-02
Study First Received: December 15, 2008
Last Updated: January 27, 2010
ClinicalTrials.gov Identifier: NCT00809146     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Status Epilepticus
Emergency Medical Services
Anticonvulsants
Drug Administration Routes
Seizures

Additional relevant MeSH terms:
Epilepsy
Therapeutic Uses
Status Epilepticus
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010