Trial · NCT05327556
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 | Change in Systolic Blood Pressure | 5 minutes prior to study drug through 5 minutes after study drug | The change in SBP from the nadir SBP prior to study drug administration to the peak SBP after study drug. The nadir SBP was defined as the lowest measurement within the 5 minutes prior to or up to 1 minute after the documented time of study drug. The peak SBP was the highest measurement with 5 minutes following study drug occurring after the nadir SBP. If an additional dose of epinephrine was administered within 5 minutes of the initial dose, the timeframe was truncated so that the peak SBP was the highest value recorded prior to the subsequent epinephrine dose. |
| Secondary | Incidence of Severe (Stage II) Hypertension | 5 minutes after study drug | The proportion of patients whose peak systolic blood pressure (determined as per the primary outcome) is greater than or equal to the 95th percentile plus 12 mmHg or greater than or equal to 140 mmHg, whichever is lower. |
| Other | Incidence of Cardiac Arrest | 0 to 120 minutes after study drug | The proportion of patients who receive chest compressions at anytime from 0 to 120 minutes after the first dose of study drug |
| Other | Incidence of Extra-corporeal Membrane Oxygenation (ECMO) | 0 to 120 minutes after study drug | The proportion of patients who are cannulated to ECMO at anytime from 0 to 120 minutes after the first dose of study drug, starting at time of first flow |
| Other | Event Survival | through 120 minutes after study drug | The proportion of patients alive 120 minutes after study drug was administered. |
| Other | Survival to Hospital Discharge | through hospital discharge, truncated at 90 days | The proportion of patients alive at time of discharge from the hospital (Truncated at 90 days) |
| Other | Change in Heart Rate (HR) | 5 minutes prior to study drug through 5 minutes after study drug | The change in HR from the nadir HR prior to study drug administration to the peak HR after study drug. The nadir HR was defined as the lowest measurement within the 5 minutes prior to or up to 1 minute after the documented time of study drug. The peak HR was the highest measurement with 5 minutes following study drug occurring after the nadir HR. If an additional dose of epinephrine was administered within 5 minutes of the initial dose, the timeframe was truncated so that the peak HR was the highest value recorded prior to the subsequent epinephrine dose. |
| Other | Change in Mean Arterial Pressure (MAP) | 5 minutes prior to study drug through 5 minutes after study drug | Difference in MAP within 5 minutes before and after study drug using measurements corresponding with the nadir and peak SBP (primary outcome). |
| Other | Change in Diastolic Blood Pressure (DBP) | 5 minutes before study drug through 5 minutes after study drug | Difference in DBP within 5 minutes before and after study drug using measurements corresponding with the nadir and peak SBP (primary outcome). |
| Other | Percent Change in SBP | 5 minutes before study drug through 5 minutes after study drug | The difference in SBP before and after study drug as defined by the primary outcome, expressed as a percentage. This was calculated by dividing the change in SBP (peak SBP minus nadir SBP) by the nadir SBP. |
| Other | Incidence of Stage I Hypertension (or Greater) | 5 minutes after study drug | The proportion of patients whose peak systolic blood pressure (as per the primary outcome) is greater than or equal to the 95th percentile or 130/80 mm Hg (whichever is lower). |
| Other | Incidence of Extreme Hypertension | 5 minutes after study drug | The proportion of patients whose peak systolic blood pressure (as per the primary outcome) is greater than or equal to the 95th percentile + 30 mm Hg or ≥170, whichever is lower. |
| Other | Incidence of Non-Responders | 5 minutes before study drug through 5 minutes after study drug | The proportion of patients who do not respond to initial dose of study drug, defined as \<10mmHg difference between nadir and peak SBP |
| Other | Proportion of Patients Requiring 1 or More Additional Doses of Epinephrine | 1 to 120 minutes after study drug | Comparison of the proportion of patients requiring 1 or more additional doses of epinephrine (study drug or open label) given in a discrete resuscitation episode up to 120 minutes after initial dose. |
| Other | Cumulative Dose of Epinephrine Per Resuscitation Episode | 0 to 120 minutes after study drug | Comparison of the cumulative dose of epinephrine (study drug or open label) in mcg/kg given in a discrete resuscitation episode up to 120 minutes after initial dose. |
| Other | Safety Outcomes -- Composite | 0 to 7 days after study drug | The proportion of patients who develop any the following prespecified safety outcomes (composite): * Any new arrhythmia within 20 minutes of first dose of study drug * Any new arrhythmia requiring intervention within 20 minutes of first dose of study drug * Intracranial hemorrhage associated with severe or extreme hypertension within 5 minutes of the first dose of study drug which is diagnosed within 7 days after the calendar day study drug was administered |
| Other | Correlation of Dose and SBP Response (Continuous) | 5 minutes prior to study drug through 5 minutes after study drug | Correlation of actual dose received in mcg/kg with change in systolic blood pressure. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05327556/registered