Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01NS056975-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| University of California, San Francisco | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular (IM) anticonvulsant | Active Comparator | This group gets active treatment with an anticonvulsant by the intramuscular route of administration. |
|
| Intravenous (IV) anticonvulsant | Active Comparator | This group gets active treatment with an anticonvulsant by the intravenous route of administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular route of active treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85742 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35987977 | Derived | Sherman NA, Silbergleit R, Bengelink EM, Durkalski V, Wolter KD. The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application. Ther Innov Regul Sci. 2023 Jan;57(1):132-141. doi: 10.1007/s43441-022-00447-4. Epub 2022 Aug 20. | |
| 24001080 | Derived | Silbergleit R, Lowenstein D, Durkalski V, Conwit R; NETT Investigators. Lessons from the RAMPART study--and which is the best route of administration of benzodiazepines in status epilepticus. Epilepsia. 2013 Sep;54 Suppl 6(0 6):74-7. doi: 10.1111/epi.12284. |
| Label | URL |
|---|---|
| RAMPART Study Public Information Web Site | View source |
Not provided
Number of patients enrolled includes any repeat enrollments for those who presented to emergency medical services (EMS) with status epilepticus more than once. The number assigned to treatment in the intention-to-treat analysis includes every patient who was enrolled in the study but only the initial enrollment for those enrolled more than once.
Subjects treated for status epilepticus in the prehospital setting by paramedics were enrolled at the scene between June 2009 and January 2011. A total of 1023 subject enrollments represented 893 unique subjects with a reenrollment rate of 13%. RAMPART involved 4314 paramedics, 33 EMS agencies, and 79 receiving hospitals across the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intramuscular (IM) Anticonvulsant | This group gets active treatment with an anticonvulsant by the intramuscular route of administration. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intravenous route of active treatment | Drug | 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. |
|
|
| anytime before 30 minutes after ED arrival |
| 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 |
| 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 |
| 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 |
| 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. | participants were followed for the duration of hospital stay, an average of 6 days |
| 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. | participants were followed for the duration of hospital stay, an average of 6 days |
| 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. | participants were followed for the duration of hospital stay, an average of 6 days |
| Length of Intensive Care Unit (ICU) Stay in Days | Continuous days of initial ICU stay from time of admission | participants were followed for the duration of hospital stay, an average of 6 days |
| Length of Hospital Stay in Days | Continuous acute care inpatient hospital days from day of admission until discharge | participants were followed for the duration of hospital stay, an average of 6 days |
| 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 |
| University of Pennsylvania/York | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University-Main Line | Philadelphia | Pennsylvania | 19140 | 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 |
| 22506949 | Derived | Silbergleit R, Biros MH, Harney D, Dickert N, Baren J; NETT Investigators. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med. 2012 Apr;19(4):448-54. doi: 10.1111/j.1553-2712.2012.01328.x. |
| 22335736 | Derived | Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012 Feb 16;366(7):591-600. doi: 10.1056/NEJMoa1107494. |
| 21967361 | Derived | Silbergleit R, Lowenstein D, Durkalski V, Conwit R; Neurological Emergency Treatment Trials (NETT) Investigators. RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial): a double-blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics. Epilepsia. 2011 Oct;52 Suppl 8(Suppl 8):45-7. doi: 10.1111/j.1528-1167.2011.03235.x. |
| FG001 |
| Intravenous (IV) Anticonvulsant |
This group gets active treatment with an anticonvulsant by the intravenous route of administration. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intramuscular (IM) Anticonvulsant | This group gets active treatment with an anticonvulsant by the intramuscular route of administration. 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. |
| BG001 | Intravenous (IV) Anticonvulsant | This group gets active treatment with an anticonvulsant by the intravenous route of administration. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Dose tier | All adults and those children with an estimated body weight of more than 40 kg received either 10 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 4 mg of intravenous lorazepam. Children with an estimated weight of 13 to 40 kg received either 5 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 2 mg of intravenous lorazepam. | Number | participants |
| |||||||||||||||
| History of epilepsy | Number | participants |
| ||||||||||||||||
| Final diagnosis | Determined by medical record review at the time of hospital discharge | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes). |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | anytime before 30 minutes after ED arrival |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | at ED disposition on day of enrollment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | at time of disposition on day of enrollment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | within 12 hours after ED arrival |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | participants were followed for the duration of hospital stay, an average of 6 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | participants were followed for the duration of hospital stay, an average of 6 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | participants were followed for the duration of hospital stay, an average of 6 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Intensive Care Unit (ICU) Stay in Days | Continuous days of initial ICU stay from time of admission | All participants with ICU length of stay data | Posted | Mean | Standard Deviation | days | participants were followed for the duration of hospital stay, an average of 6 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay in Days | Continuous acute care inpatient hospital days from day of admission until discharge | All subjects with hospital length of stay data | Posted | Mean | Standard Deviation | days | participants were followed for the duration of hospital stay, an average of 6 days |
|
|
Serious adverse events were collected through subject end of study (emergency department or hospital discharge).
Number of participants at risk includes every enrollment (including repeat enrollments in some subjects). This reflects the number of interventions given.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IM Midazolam | Subjects in whom the study IM autoinjector contained active treatment with midazolam | 137 | 514 | 103 | 514 | ||
| EG001 | IV Lorazepam | Subjects in whom the study IV infusion contained active treatment with lorazepam | 156 | 509 | 95 | 509 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depressed level of consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Mental status changes | Nervous system disorders | Non-systematic Assessment |
| ||
| Sepsis/SIRS/organ failure | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia/ Aspiration pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| ||
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Alcohol/Drug withdrawal syndrome | General disorders | Non-systematic Assessment |
| ||
| Cerebral hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal failure, acute | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Ischemic stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Hypothermia | General disorders | Non-systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Brain mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Delirium | Nervous system disorders | Non-systematic Assessment |
| ||
| Hematoma | General disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hyperglycemic hyperosmolar nonketotic syndrome | Endocrine disorders | Non-systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Subarachnoid hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Transfusion reaction | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Pseudoseizures | Psychiatric disorders | Non-systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Post-extubation stridor/airway obstruction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Psychosis | Psychiatric disorders | Non-systematic Assessment |
| ||
| Stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Vomiting/Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Mental status changes | Nervous system disorders | Non-systematic Assessment |
| ||
| Vomiting/Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Silbergleit MD, Principal Investigator | University of Michigan | 734-232-2142 | robie@umich.edu |
| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 6-10 years |
|
| 11-20 years |
|
| 21-40 years |
|
| 41-60 years |
|
| >61 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Children estimated >40kg and All Adults |
|
| No |
|
| Not documented |
|
| Nonepileptic spell |
|
| Undetermined |
|
Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|