Critically IllUFANINCT06285162
Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy
An observational study of Critically Ill and Renal Replacement Therapy, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Renal Replacement Therapy
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with continuous renal replacement therapy, fluid overload and haemodynamically stable.
Who may be able to join
- 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
Show all 9Show fewer
- Central venous line in superior vena cava territory
- Regular sinus rhythm
- Patient awake or Richmond Agitation and Sedation Scale > -3
Who cannot join
- 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
Show all 9Show fewer
- Opposition to participate
- Adults under legal protection
- Persons deprived of their liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel
Bron, 69500
Martin RUSTE, MD, +33472118956 ext. +33, martin.ruste@chu-lyon.fr
Martin RUSTE, MD
About this study
Official title: Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
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.
- Conditions
- Critically Ill, Renal Replacement Therapy
- Keywords
- Analgesia Nociception Index, R-R interval, autonomic nervous system, haemodynamic, fluid removal
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with continuous renal replacement therapy. | The patients will be followed during the first 6 hours of the initiation of a net ultrafiltration (2-3 milliliters/kilograms/hour) with continuous monitoring (R-R interval, ANI, cardiac index, invasive arterial pressure, central venous pressure, peripheral perfusion index), and perfusion monitoring every 6 hours (arterial lactate, central venous oxygen saturation, capillary refill time, mottling score). Such a fluid removal strategy is part of an institutional protocol or an ongoing clinical trial. In addition to the usual monitoring, the PhysioDoloris monitor will be connected to the patient's scope. The ANI and its parameters will be recorded continuously throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after initiation of net ultrafiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start9 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin RUSTE, MD, Principal investigator, Département d'anesthésie-réanimation, Hôpital cardiologique Louis Pradel, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285162
- Sponsor's protocol ID
- 69HCL23_1372
- Other IDs
- 2024-A00294-43
- Acronym
- UFANI
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
- ClinicalTrials.gov ID
- NCT06285162
- Acronym / sponsor ID
- UFANI / 69HCL23_1372
- Conditions
- Critically Ill, Renal Replacement Therapy
- Keywords
- Analgesia Nociception Index, R-R interval, autonomic nervous system, haemodynamic, fluid removal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with continuous renal replacement therapy. | – | –The patients will be followed during the first 6 hours of the initiation of a net ultrafiltration (2-3 milliliters/kilograms/hour) with continuous monitoring (R-R interval, ANI, cardiac index, invasive arterial pressure, central venous pressure, peripheral perfusion index), and perfusion monitoring every 6 hours (arterial lactate, central venous oxygen saturation, capillary refill time, mottling score). Such a fluid removal strategy is part of an institutional protocol or an ongoing clinical trial. In addition to the usual monitoring, the PhysioDoloris monitor will be connected to the patient's scope. The ANI and its parameters will be recorded continuously throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with continuous renal replacement therapy, fluid overload and haemodynamically stable.
Key inclusion criteria (9 listed)
- 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):
- Invasive blood pressure monitoring
- Central venous line in superior vena cava territory
- Regular sinus rhythm
Key exclusion criteria (9 listed)
- Ongoing administration of inotropes
- Ongoing administration of beta blockers
- Current administration of alpha-2 agonists
- History of dysautonomia
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin RUSTE, MD principal investigator
Département d'anesthésie-réanimation, Hôpital cardiologique Louis Pradel, HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Renal Replacement Therapy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin RUSTE, MD (+33472118956 ext. +33, martin.ruste@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of changes in ANI. (time frame: 6 hours after initiation of net ultrafiltration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.