Analgesia Nociception Index monitoring of the autonomic nervous system during continuous renal replacement therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational protocol that continuously records the Analgesia Nociception Index (ANI) alongside invasive hemodynamic measurements in ICU patients on continuous renal replacement therapy (CRRT) undergoing net ultrafiltration. Eligible patients have invasive arterial and central venous monitoring, regular sinus rhythm, and meet local fluid-overload and stability criteria, while patients on inotropes, beta-blockers, or with dysautonomia are excluded. ANI and standard vital signs will be captured before, during, and after fluid removal and analyzed for temporal associations with blood pressure and heart rate changes. No changes to clinical care are mandated by the protocol; data are collected from routine CRRT sessions to characterize autonomic-related hemodynamic variation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel
  Bron, France Recruiting

Study contacts

• Principal investigator: Martin RUSTE, MD — Département d'anesthésie-réanimation, Hôpital cardiologique Louis Pradel, HCL
• Study coordinator: Martin RUSTE, MD
• Email: martin.ruste@chu-lyon.fr
• Phone: +33472118956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.