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临床试验/NCT04578288
NCT04578288已完成不适用

Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Functional outcome 90 days after stroke onset

研究概览

简要总结

Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).

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
None

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

  • Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
  • Age 18 years or older, either sex
  • National Institutes of Health Stroke Scale (NIHSS) ≥ 8
  • Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
  • Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment

排除标准

  • Intracerebral hemorrhage
  • Coma on admission (Glasgow Coma Scale ≤ 8)
  • Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
  • Intubated state before randomization
  • Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)

结局指标

主要结局

Functional outcome 90 days after stroke onset

时间窗: 90 days

modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).

次要结局

  • Infarction size, determined with MRI or (in case of contraindications CT scan) 12-36 h after admission on a post-interventional follow up scan [milliliter](12-36 hours)
  • Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission(24 hours)
  • Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion](Duration of thrombectomy procedure up to 240 minutes)
  • Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion](Duration of thrombectomy procedure up to 240 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Silvia Schönenberger, MD

Principal Investigator, Co-principal investigator: Dr. Min Chen, MD

University Hospital Heidelberg

研究点 (2)

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