Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critically Ill, Renal Replacement Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
Overview
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.
Primary outcome measures
- Percentage of changes in ANI. [Time frame: 6 hours after initiation of net ultrafiltration]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel — Bron
Identifiers
NCT: NCT06285162 · 69HCL23_1372 · 2024-A00294-43