NICardipine for Fast Achievement of Systolic BP Targets in ICH
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Nicardipine, Glyceryl trinitrate.
- Кому может быть актуально
- Состояния в реестре: Intracerebral Haemorrhage. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.
Обзор
Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP \<140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.
Подробное описание
Spontaneous intracerebral hemorrhage (ICH) is one of the most time-critical neurological emergencies. Rapid lowering of systolic blood pressure to below 140 mmHg (but not below 110 mmHg) has been associated with reduced risk of hematoma expansion and improved long-term functional outcomes. International guidelines recommend that the target blood pressure be achieved within 1 hour of hospital admission.
Traditionally, the specific class of antihypertensive agent used for acute blood pressure management in ICH was considered less important than achieving the target level. However, emerging evidence from two randomized clinical trials has raised concerns regarding the safety of transdermal long-acting nitrate patches (such as glyceryl trinitrate) in the hyperacute phase of stroke. These studies reported signals suggesting potential harm when nitrate patches were used in the early hours after symptom onset. Further, the time from derug administration to blood-pressure control is longer than intravenous administration.
In contrast, intravenous calcium channel blockers such as nicardipine have demonstrated both efficacy and safety in achieving rapid blood pressure control in acute ICH. These agents are widely used in clinical practice and are recommended in national and international guidelines.
In our institution, the standard protocol for acute blood pressure management in ICH has historically included transdermal glyceryl trinitrate patches. In light of emerging safety concerns and new recommendations, we aim to gradually implement a revised protocol centered on intravenous nicardipine. The implementation will be conducted in a cluster randomized stepwise fashion and monitored closely for its effects on blood-pressure control, safety, workflow, and resource utilization.
Вмешательства
- Комбинированный продукт Nicardipine
Nicardipine infusion based acute blood pressure lowering treatment - Комбинированный продукт Glyceryl trinitrate
Glyceryltrinitrate based acute blood pressure lowering treatment
Первичные конечные точки
- Target blood pressure < 140 mmHg 1 hour after admission. [Срок оценки: 1 hour after stroke center admission]
Вторичные конечные точки (12)
- Functional outcome at 3 months [Срок оценки: 90 days (+/- 14 days)]
- Bed day use [Срок оценки: 0 to 180 days]
- Total bed day use [Срок оценки: 0 to 180 days]
- Serious adverse events [Срок оценки: 90 days]
- Hypotension [Срок оценки: 0 to 90 days]
- Acute kidney injury [Срок оценки: 0 to 90 days]
- Reduced level of consciousness [Срок оценки: 0 to 90 days]
- Intensive care unit [Срок оценки: 0 to 90 days]
- Neurosurgery [Срок оценки: 0 to 90 days]
- Mortality [Срок оценки: 90 days (+/- 14 days)]
- Mortality [Срок оценки: 180 days (+/- 14 days)]
- Systolic bloodpressure at 1 hour [Срок оценки: 1 hour]
Критерии участия
Критерии включения
- Age ≥18 years
- Acute spontaneous Intracerberal Hemorrhage confirmed by imaging
- Symptom onset to stroke center admission <6 hours
- Elevated systolic blood pressure (>140 mmHg) at admission
Критерии исключения
- Secondary causes of ICH (e.g., trauma, vascular malformation)
- Presumed fatal bleeding at admission
- Short remaining life expectancy (<12 month)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Aarhus University Hospital — Aarhus
Идентификаторы
NCT: NCT07044232 · NICFAST