NCT06285162招募中不适用
Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of changes in ANI.
研究概览
简要总结
The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous renal replacement therapy in intensive care unit
- •Initiation of net ultrafiltration according to the protocol of the department or to EARLYDRY study (NCT 05817539) (3 criteria required):
- •Fluid overload > 5% or peripheral oedema
- •Noradrenaline equivalent <0.5μg/kg/min
- •No peripheral hypoperfusion
- •Invasive blood pressure monitoring
- •Central venous line in superior vena cava territory
- •Regular sinus rhythm
- •Patient awake or Richmond Agitation and Sedation Scale > -3
排除标准
- •Ongoing administration of inotropes
- •Ongoing administration of beta blockers
- •Current administration of alpha-2 agonists
- •History of dysautonomia
- •Pregnant or breast-feeding woman
- •Mechanical circulatory assistance
- •Opposition to participate
- •Adults under legal protection
- •Persons deprived of their liberty by judicial or administrative decision
结局指标
主要结局
Percentage of changes in ANI.
时间窗: 6 hours after initiation of net ultrafiltration
Relative changes in ANI (averaged over 4 minutes (percentage)) between Hour 0 and Hour 6 of initiation of net ultrafiltration.
次要结局
未报告次要终点
研究者
研究点 (1)
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