跳至主要内容
临床试验/NCT06285162
NCT06285162
招募中
不适用

Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 30 人2026年1月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Critically Ill
发起方
Hospices Civils de Lyon
入组人数
30
试验地点
1
主要终点
Percentage of changes in ANI.
状态
招募中
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2026年1月9日
结束日期
2027年4月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

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.

研究点 (1)

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