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NCT06285162 Clinical Trial

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

Critically Ill Clinical Trial

— UFANI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06285162
Other study ID # 69HCL23_1372
Secondary ID 2024-A00294-43
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date July 2025

Study information
Verified date February 2024
Source Hospices Civils de Lyon
Contact Martin RUSTE, MD
Phone +33472118956
Email martin.ruste@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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