跳至主要内容
临床试验/NCT07044232
NCT07044232招募中4 期

NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
88
试验地点
1
主要终点
Target blood pressure < 140 mmHg 1 hour after admission.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors for 90 days modified Rankin Scale

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Secondary causes of ICH (e.g., trauma, vascular malformation)
  • Presumed fatal bleeding at admission
  • Short remaining life expectancy (<12 month)

结局指标

主要结局

Target blood pressure < 140 mmHg 1 hour after admission.

时间窗: 1 hour after stroke center admission

Proportion of patients reaching systolic BP \<140 mmHg within 1 hour of stroke center admission

次要结局

  • Functional outcome at 3 months(90 days (+/- 14 days))
  • Bed day use(0 to 180 days)
  • Total bed day use(0 to 180 days)
  • Serious adverse events(90 days)
  • Hypotension(0 to 90 days)
  • Acute kidney injury(0 to 90 days)
  • Reduced level of consciousness(0 to 90 days)
  • Intensive care unit(0 to 90 days)
  • Neurosurgery(0 to 90 days)
  • Mortality(180 days (+/- 14 days))

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rolf Blauenfeldt

MD, PhD, Associate Professor

Aarhus University Hospital

研究点 (1)

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