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

NCT ID: NCT06285162

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-09
• Study Completion Date: 2027-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin RUSTE, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martin RUSTE, MD

Role: CONTACT

martin.ruste@chu-lyon.fr

+33472118956 ext. +33

Facility Contacts

Martin RUSTE, MD

Role: primary

martin.ruste@chu-lyon.fr

+33472118956 ext. +33

Other Identifiers

2024-A00294-43

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_1372

Identifier Type: -

Identifier Source: org_study_id