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

NCT06285162 | Recruiting

• 2 other identifiers: 69HCL23_13722024-A00294-43
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critically Ill; Renal Replacement Therapy

Keywords

Analgesia Nociception Index; R-R interval; autonomic nervous system; haemodynamic; fluid removal

Outcome Measures

Primary Outcomes (1)

• Percentage of changes in ANI.

  Relative changes in ANI (averaged over 4 minutes (percentage)) between Hour 0 and Hour 6 of initiation of net ultrafiltration.

  6 hours after initiation of net ultrafiltration

Study Arms (1)

Critically ill patients with continuous renal replacement therapy.

The patients will be followed during the first 6 hours of the initiation of a net ultrafiltration (2-3 milliliters/kilograms/hour) with continuous monitoring (R-R interval, ANI, cardiac index, invasive arterial pressure, central venous pressure, peripheral perfusion index), and perfusion monitoring every 6 hours (arterial lactate, central venous oxygen saturation, capillary refill time, mottling score). Such a fluid removal strategy is part of an institutional protocol or an ongoing clinical trial. In addition to the usual monitoring, the PhysioDoloris monitor will be connected to the patient's scope. The ANI and its parameters will be recorded continuously throughout the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with continuous renal replacement therapy, fluid overload and haemodynamically stable.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin RUSTE, MD

  Département d'anesthésie-réanimation, Hôpital cardiologique Louis Pradel, HCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin RUSTE, MD

CONTACT

+33472118956; martin.ruste@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)