Actively Recruiting

Age: 18Years +
All Genders
ID06285162

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

Led by Hospices Civils de Lyon · Updated on 2026-01-15

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the Analgesia Nociception Index (ANI), which reflects the balance between the sympathetic and parasympathetic nervous systems by analyzing variations in heart rate intervals. This study focuses on patients undergoing continuous renal replacement therapy (CRRT) who experience fluid overload and receive net ultrafiltration. The goal is to investigate how ANI changes during fluid removal and how these changes relate to hemodynamic variations caused by the autonomic nervous system. Participants will be monitored during the first six hours after starting net ultrafiltration at a rate of 2-3 milliliters per kilogram per hour. Continuous monitoring includes measuring R-R interval, ANI, cardiac index, invasive arterial pressure, central venous pressure, and peripheral perfusion index. Additional perfusion assessments such as arterial lactate, central venous oxygen saturation, capillary refill time, and mottling score will be performed every six hours. The PhysioDoloris monitor will be attached to the patient's scope to record ANI and related parameters continuously throughout the study. During participation, patients will be closely observed in the intensive care unit with invasive blood pressure and central venous line monitoring. Data collection will focus on the percentage change in ANI six hours after starting net ultrafiltration. The study aims to correlate these autonomic nervous system measurements with hemodynamic changes. The total monitoring period is six hours after initiation of the fluid removal process, providing detailed insight into how the autonomic system responds to therapy in critically ill patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receiving continuous renal replacement therapy in an intensive care unit
  • Starting net ultrafiltration according to the department protocol or EARLYDRY study, meeting all three: fluid overload over 5% or peripheral edema, noradrenaline equivalent less than 0.5µg/kg/min, and no peripheral hypoperfusion
  • Invasive blood pressure monitoring
  • Central venous line placed in the superior vena cava territory
  • Regular sinus rhythm
  • Patient is awake or has Richmond Agitation and Sedation Scale greater than -3
Not Eligible

You will not qualify if you...

  • Currently receiving inotropes
  • Currently taking beta blockers
  • Currently using alpha-2 agonists
  • History of dysautonomia
  • Pregnant or breastfeeding women
  • Receiving mechanical circulatory assistance
  • Refusal to participate
  • Adults under legal protection
  • Persons deprived of liberty by judicial or administrative decision

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 6 hours

Participants are continuously monitored during the first 6 hours after starting net ultrafiltration as part of their continuous renal replacement therapy. This includes continuous recording of the Analgesia Nociception Index and other physiological parameters.

Continuous monitoring during 6 hours

Surveillance

Duration - Ongoing as per clinical protocol

Participants undergo perfusion monitoring every 6 hours following the initial 6-hour monitoring period as part of standard care.

Perfusion assessments every 6 hours

Trial Site Locations

Total: 1 location

1

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel

Bron, France, 69500

Actively Recruiting

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Research Team

M

Martin RUSTE, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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