Analgesia Nociception Index monitoring of the autonomic nervous system during continuous renal replacement therapy
Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
We will try using the Analgesia Nociception Index to see if changes in autonomic signals match blood pressure and heart responses when fluid is removed during continuous renal replacement therapy in critically ill adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT06285162 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult ICU patients receiving continuous renal replacement therapy who are undergoing net ultrafiltration, have invasive arterial and central venous lines, are in regular sinus rhythm, are not receiving inotropes or certain chronotropic agents, and meet the department's fluid-overload criteria would be ideal candidates.
Not a fit: Patients with arrhythmias, on inotropes, beta-blockers, or alpha-2 agonists, those with known dysautonomia, pregnant or breastfeeding patients, or those lacking invasive monitoring are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could help clinicians detect autonomic-driven hemodynamic instability during fluid removal and guide safer ultrafiltration choices.
How similar studies have performed: ANI has been used to monitor autonomic tone and nociception in anesthesia and some ICU settings, but applying it specifically to hemodynamic effects during ultrafiltration in CRRT is novel and only sparsely studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bron
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.