Trial · NCT01960075
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat |
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Per-protocol analysis |
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. The Adjudicated outcomes analysis is different from Outcome measure 1 because a central clinical phenomenology core of four neurologists adjudicated from the medical records the time to seizure cessation, the time in status epilepticus before trial-drug initiation, and the cause of the seizure. For each enrollment, two neurologists from this core group conducted independent initial reviews and then determined a consensus or consulted a third adjudicator, as needed. Adjudicators were unaware of the treatment assignments and made determinations by medical record review. |
| Secondary | Number of Participants With Admission to Intensive Care Unit | Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient | ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. |
| Secondary | Length of ICU Stay | number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study | Length of stay is determined by the number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study. |
| Secondary | Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success | start of drug infusion to seizure cessation | The time to termination of seizures is the interval from the start of study drug infusion to cessation of clinically apparent seizure in those who meet the primary outcome. |
| Secondary | Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success | within 20 minutes | Number of participants with seizure cessation within 20 minutes of study drug initiation for patients with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper. |
| Secondary | Length of Hospital Stay | length of hospital stay | Length of hospital stay in days |
| Other | Number of Participants With Safety Outcome: Life Threatening Hypotension | within 60 minutes of the start of study drug infusion | Life-threatening hypotension within 60 minutes of the start of study drug infusion |
| Other | Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia | within 60 minutes of the start of study drug infusion | Life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion |
| Other | Number of Participants With Safety Outcome: Endotracheal Intubation | within 60 minutes of start of study drug infusion | Endotracheal intubation within 60 minutes of start of study drug infusion |
| Other | Number of Participants With Safety Outcome: Acute Anaphylaxis | within 6 hours of the start of study drug infusions | Acute anaphylaxis is defined as a clinical presentation consistent with life threatening allergic reaction occurring within 6 hours of the start of study drug infusions and manifested as urticaria in combination with either (1) a systolic blood pressure of \< 90 mmHg sustained for greater than 5 minutes, or (2) objective evidence of airway obstruction, and for which the patient was treated with antihistamines and/or steroids. |
| Other | Number of Participants With Safety Outcome: Acute Respiratory Depression | 24 hours | Respiratory depression is defined as impairment of ventilation or oxygenation necessitating definitive endotracheal intubation and mechanical ventilation. It is distinct from intubations performed only for airway protection in those with decreased levels of consciousness. It does not include those getting only supraglottic airways or transient bag-valve-mask support. |
| Other | Number of Participants With Safety Outcome: Hepatic Transaminase or Ammonia Elevations | 24 hours | Safety outcome: Hepatic transaminase or ammonia elevations |
| Other | Number of Participants With Safety Outcome: Purple Glove Syndrome | 24 hours | Purple glove syndrome is defined as the presence of all three of the findings of the objective edema: discoloration, and pain in the distal extremity in which study drug was administered, with or without known extravasation, and for which there is no other evident etiology. |
| Other | Number of Participants With Safety Outcome: Death | 30 days | Safety outcome: Death |
| Other | Number of Participants With Safety Outcome: Acute Seizure Recurrence | 60 minutes to 12 hours after start of study drug infusion | acute seizure recurrence 60 minutes to 12 hours after start of study drug infusion |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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