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Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: Intramuscular route of active treatment (Drug); Intravenous route of active treatment (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Robert Silbergleit

Official(s) and/or principal investigator(s):
Robert Silbergleit, MD, Principal Investigator, Affiliation: University of Michigan
Daniel H Lowenstein, MD, Principal Investigator, Affiliation: University of California, San Francisco
Valerie L Durkalski, PhD, Principal Investigator, Affiliation: Medical University of South Carolina

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given

Secondary outcome:

Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival

Number of Subjects Hospitalized

Number of Subjects Admitted to an Intensive Care Unit (ICU)

Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival

Number of Subjects With Hypotension

Number of Subjects With IM Injection-site Complications

Number of Subjects With IV Injection-site Complications

Length of Intensive Care Unit (ICU) Stay in Days

Length of Hospital Stay in Days

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, the Rapid Anti-convulsant Medication Prior to ARrival Trial (RAMPART), 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 1,024 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). In September 2010, more rapid than expected enrollment made it feasible to increase the sample size of the study from 800 to 1,024 with the already available funding. The goals of the expansion were to enroll more pediatric subjects (since the trial was enrolling slightly fewer than anticipated) and to improve the power of the study to 90%, which was initially desired. It is important to understand that the extended enrollment was not a sample size re-estimation in any way. The opportunity to extend the trial is pragmatic, based solely on the early enrollment success of the trial. It is not informed by the planned interim analyses that have been performed, the results of which remain sequestered, and there have been no unscheduled interim analyses. The firewall that prevents the blinded leadership from any knowledge of the outcome data has been diligently maintained throughout the process of proposing and implementing this extension.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Arizona, Tucson, Arizona 85742, United States

Stanford University, Palo Alto, California 94304-5777, United States

University of California-San Francisco, San Francisco, California 94110, United States

Emory University, Atlanta, Georgia 30303, United States

University of Kentucky, Lexington, Kentucky 40536-0298, United States

University of Maryland, Baltimore, Maryland 21201, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Wayne State University, Detroit, Michigan 48202, United States

University of Minnesota, Minneapolis, Minnesota 55414, United States

New York Presbyterian Hospital, New York, New York 10032, United States

University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States

Oregon Health and Science University, Portland, Oregon 97239-3098, United States

Temple University-Main Line, Philadelphia, Pennsylvania 19140, United States

University of Pennsylvania/York, Philadelphia, Pennsylvania 19104, United States

University of Texas-Houston, Houston, Texas 77030, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

RAMPART Study Public Information Web Site

Starting date: June 2009
Last updated: April 13, 2012

Page last updated: August 23, 2015

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