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

Not yet recruiting

• Conditions: Renal Replacement Therapy; Critically Ill

• Registration Number: NCT06285162
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-22
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29
• Study Start: 2024-04
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel; 🇫🇷 Bron, France