Status Epilepticus Clinical Trial
— RAMPARTOfficial 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
Verified date | April 2012 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1023 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | University of Maryland | Baltimore | Maryland |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Wayne State University | Detroit | Michigan |
United States | University of Texas-Houston | Houston | Texas |
United States | University of Kentucky | Lexington | Kentucky |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | New York Presbyterian Hospital | New York | New York |
United States | Stanford University | Palo Alto | California |
United States | Temple University-Main Line | Philadelphia | Pennsylvania |
United States | University of Pennsylvania/York | Philadelphia | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | University of California-San Francisco | San Francisco | California |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Robert Silbergleit | Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS), University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given | The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing. | Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes). | No |
Secondary | Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival | Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation. | anytime before 30 minutes after ED arrival | Yes |
Secondary | Number of Subjects Hospitalized | Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. | at ED disposition on day of enrollment | Yes |
Secondary | Number of Subjects Admitted to an Intensive Care Unit (ICU) | Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. | at time of disposition on day of enrollment | Yes |
Secondary | Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival | Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival. | within 12 hours after ED arrival | Yes |
Secondary | Number of Subjects With Hypotension | Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor. | during hospitalization | Yes |
Secondary | Number of Subjects With IM Injection-site Complications | IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems. | during hospitalization | Yes |
Secondary | Number of Subjects With IV Injection-site Complications | IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care. | during hospitalization | Yes |
Secondary | Length of Intensive Care Unit (ICU) Stay in Days | Continuous days of initial ICU stay from time of admission | during hospitalization | No |
Secondary | Length of Hospital Stay in Days | Continuous acute care inpatient hospital days from day of admission until discharge | during hospitalization | No |
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