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Clinical Trials in France / NCT06285162
Recruiting Observational

Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy

NCT06285162 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Observational
Started
2026-01-09
Last updated
2026-01-15

Condition(s) studied

Critically IllRenal Replacement Therapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of changes in ANI. — 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.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06285162 on ClinicalTrials.gov ↗ ← All trials in France