Recruiting

NCT Number: NCT06285162

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

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.

Recruiting

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Replacement Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel

Bron, 69500, France

Location status: Recruiting

Location contact

Martin RUSTE, MD

CONTACT

[email protected]

+33472118956 ext. +33

Martin RUSTE, MD

PRINCIPAL_INVESTIGATOR

Matthias JACQUET-LAGREZE, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Percentage of changes in ANI.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin RUSTE, MD

CONTACT

[email protected]

+33472118956 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.

Acronym: UFANI

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 29, 2024
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed