跳至主要内容
临床试验/NCT06759259
NCT06759259已完成不适用

Mannitol Adjuvant Administration for Delerium Prevention

Tomsk National Research Medical Center of the Russian Academy of Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月29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
50
试验地点
2
主要终点
delirium

研究概览

简要总结

The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.

详细描述

The pathogenesis of delirium in patients with myocardial infarction has not been fully studied, as a result of which delirium is currently considered a polyetiological syndrome. The ideas about the pathogenesis of delirium are formulated in a number of concepts, among which the neuroinflammatory theory is the most promising for study. The development of a systemic inflammatory reaction of both infectious and aseptic nature can lead to a violation of the permeability of the blood-brain barrier, followed by subclinical cerebral edema and impaired neurotransmitter metabolism. A single study of the adjuvant use of mannitol for the prevention of delirium, conducted in 2020 (Hamiko M.) proved the effectiveness of mannitol in the prevention of delirium in patients who underwent surgical aortic valve replacement, and served as a theoretical and experimental prerequisite for this study.

The study is prospective, randomized, open-label, controlled. It is planned to include 40 patients with myocardial infarction aged 65 years or older on the first day of the disease ("pain-door" < 24 hours) and signs of a systemic inflammatory response (CRP> 25 mg / L) in the main and control groups in a 1: 1 ratio. All patients will receive standard treatment for myocardial infarction upon admission in accordance with current recommendations. Patients will be randomized using a random number generator, after which patients in the main group will receive adjuvant therapy with mannitol at a dose of 1000 mg / kg according to the following scheme: bolus 250 mg / kg + infusion 66.6 mg / kg / hour until a total dose of 1000 mg / kg is reached. Patients in the control group will receive standard treatment for myocardial infarction. It is planned to evaluate clinical, laboratory, functional data and take blood samples for the study of markers of systemic inflammation and brain damage and other biomarkers on days 1, 3 and 7. Evaluation of remote outcomes is planned on days 30 and 90.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age 65 and over
  • Myocardial infarction in the first day of illness ("pain to door" time < 254 hours)
  • Serum CRP > 25 mg/L

排除标准

  • A known pathological process in the brain, psychiatric disorders
  • Impossibility of conducting an assessment CAM-ICU

结局指标

主要结局

delirium

时间窗: 1-14 days

Development of delirium during hospitalization

次要结局

  • ICU-LOS(1-30 days)
  • In-hospital mortality(1-30 days)
  • In-hospital LOS(1-30 lays)
  • Re-hospitalization due to MACE(1-90 days)

研究者

研究点 (2)

Loading locations...

相似试验