CongestionOBHIMERNCT06799910
Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
A study testing continuous renal replacement therapy (CRRT) and Free UF Prescription in people with Congestion and RRT, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestion, RRT, UF
- What is being tested?
- continuous renal replacement therapy (CRRT) and Free UF Prescription
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2024to Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- The patient was hospitalized in the intensive care unit of Amiens-Picardie University Hospital.
- Patient with an increase in fluid balance (TBW > 5%)
- Patient receiving continuous veno-venous hemofiltration (CVVH) on a PrismaFlexR or PrisMaxR machine, initiated due to oliguria, potassium level > 6.5 mmol/L, urea level > 25 mmol/L, or creatinine > 300 µmol/L and severe metabolic acidosis (pH < 7.2).
- Hemodynamically stable patient with a mean arterial pressure (MAP) > 65 mmHg for more than 4 hours with norepinephrine.
- Signed consent to participate in the study by the patient or, if unconscious, their legal representative/next of kin.
Who cannot join
- Invalid BIA measurements
- Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
- Cardiac arrhythmia (atrial fibrillation, atrial flutter) present at the inclusion
- Chronic dialysis patient
- Moribund patient
- The patient is on extracorporeal mechanical support
Show all 9Show fewer
- Hemorrhagic shock
- Pregnant woman
- Patient under guardianship or conservators.
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
CHRU Amiens
Salouël, 80480
Christophe Beyls, MD, 33 + 03 22 08 78 66, beyls.christophe@chu-amiens.fr
About this study
In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. When diuretics fail, RRT, typically through continuous renal replacement therapy (CRRT), is recommended. However, prescribing the correct level of UF is challenging; insufficient UF can worsen edema, while excessive UF risks hemodynamic instability. This pilot, single-center, prospective, interventional, randomized, controlled, open-label study includes two parallel groups: a standard group with UF prescribed by the physician based on clinical and hemodynamic status and an experimental group with UF guided by the extracellular to total body water (ECW/TBWat) ratio measured by BIA. The aim is to determine if ECW/TBW-guided UF improves fluid and TBW reduction over a 72-hour RRT period.
- Conditions
- Congestion, RRT, UF, Bio-impendance Analysis, Fluid Removal, Diuretics
- Being tested
- continuous renal replacement therapy (CRRT), Free UF Prescription
- Keywords
- bio-impendance analysis, fluid removal, diuretics, overload, congestion, RRT, UF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapy (CRRT)Procedure or surgery
The patient is included in the study once they meet the eligibility criteria and as soon as the responsible physician has prescribed RRT according to the department's protocol. Randomization will be performed, and the patient will be assigned to either the standard or experimental groups.
Free UF PrescriptionOther
The UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition.
| Study group | Role | What they receive |
|---|---|---|
| Free UF Prescription | Active comparator | Free UF Prescription :
The UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition. Receives: Procedure: continuous renal replacement therapy (CRRT) |
| UF Prescription Guided by the ECW/TBWat Ratio | Experimental | Experimental Group - UF Prescription Guided by the ECW/TBWat Ratio :
* In the experimental group, the patient will receive a prescription for UF guided by the ECW/TBWat ratio. The goal is to achieve an ECW/TBWat ratio of less than 0.400 by the end of the 72-hour RRT session.
* To meet this objective, the physician must measure the ECW/TBWat ratio each time the UF is adjusted. If the patient's ECW/TBWat ratio is less than 0.400 at the measurement time, the goal is to maintain it below 0.400 during the RRT session.
* To calculate the ECW/TBWATratio, the Inbody BWA 2.0 device requires the initial TBW, which will be measured by the Hill-Room Acella 900 bed (Hill-Room, Batesville, USA).
* The ratio is calculated by the Inbody BWA 2.0 and is based on the average of 3 consecutive measurements.
* The physician determines the prescription for adjusting the UF (ml/h) based on the patient's hemodynamic and clinical condition during the RRT session. Receives: Other: Free UF Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of TBW between both groups
To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.
Measured: at 72 hours
Secondary outcomes (35)
Variation of cumulative net UF
The net UF is the difference between the fluids removed by RRT and the replacement fluids infused before and after the RRT filter. The cumulative net UF is the UF measured from H0 to H72. The volume of UF and infused replacement fluid will be calculated using data extracted from the memory card of the RRT machine.
Measured: at 72 hours
Measurement of the net UF rate
Measurement of the net UF rate (ml/kg/h): The net UF rate is calculated as follows: cumulative net UF / (TBW at H0) x effective treatment duration during the 72 hours of the study. The treatment duration will be measured using data extracted from the memory card of the RRT machine.
Measured: at 72 hours
Measurement of the ECW/TBWATratio and its association with the VeXUS score
Measurement of the ECW/TBWATratio and its association with the VeXUS score at H0 . The VeXUS score is an echocardiographic score (ranging from 0 to 3) used to analyze venous congestion at the cardiac, renal, and hepatic levels.
Measured: day 0
Measurement of the ECW/TBWATratio and its association with the VeXUS score
Measurement of the ECW/TBWATratio and its association with the VeXUS score at H72 . The VeXUS score is an echocardiographic score (ranging from 0 to 3) used to analyze venous congestion at the cardiac, renal, and hepatic levels.
Measured: at 72 hours
Measurement of the ECW/TBWAT ratio
Measurement of the ECW/TBWATratio and its association with conventional right heart function parameters and those evaluated by speckle tracking at H0. The speckle tracking-based parameters used will measure: (a) Longitudinal displacement of the septal and lateral walls and right ventricular shortening; (b) Global longitudinal strain and free wall strain of the right ventricle and (c) Right atrial strain (reservoir, conduit, and contraction phases). The parameters will be measured offline using the QLAB 15.0 software (Philips Healthcare).
Measured: day 0
Measurement of the ECW/TBWAT ratio
Measurement of the ECW/TBWATratio and its association with conventional right heart function parameters and those evaluated by speckle tracking at H72. The speckle tracking-based parameters used will measure: (a) Longitudinal displacement of the septal and lateral walls and right ventricular shortening; (b) Global longitudinal strain and free wall strain of the right ventricle and (c) Right atrial strain (reservoir, conduit, and contraction phases). The parameters will be measured offline using the QLAB 15.0 software (Philips Healthcare).
Measured: 72 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Measured: at 24 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Measured: at 48 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Measured: at 72 hours
duration of use for each filter in both groups
complications related to RRT in both groups : duration of use for each filter in both groups
Measured: at 24 hours
duration of use for each filter in both groups
complications related to RRT in both groups : duration of use for each filter in both groups
Measured: at 48 hours
duration of use for each filter in both groups
complications related to RRT in both groups : duration of use for each filter in both groups
Measured: at 72 hours
Number of hypotensive episodes during dialysis
Number of hypotensive episodes during dialysis: A hypotensive episode is defined as a mean arterial pressure (MAP) < 65 mmHg for 1 minute, measured using hemodynamic monitoring
Measured: at 24 hours
Number of hypotensive episodes during dialysis
Number of hypotensive episodes during dialysis: A hypotensive episode is defined as a mean arterial pressure (MAP) < 65 mmHg for 1 minute, measured using hemodynamic monitoring
Measured: at 48 hours
Number of hypotensive episodes during dialysis
Number of hypotensive episodes during dialysis: A hypotensive episode is defined as a mean arterial pressure (MAP) < 65 mmHg for 1 minute, measured using hemodynamic monitoring
Measured: at 72 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Measured: at 24 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Measured: at 48 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Measured: at 72 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Measured: at 24 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Measured: at 48 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Measured: at 72 hours
Measurement of serum potassium
Measurement of serum potassium
Measured: at 24 hours
Measurement of serum potassium
Measurement of serum potassium
Measured: at 48 hours
Measurement of serum potassium
Measurement of serum potassium
Measured: at 72 hours
Measurement of serum phosphate
Measurement of serum phosphate
Measured: at 24 hours
Measurement of serum phosphate
Measurement of serum phosphate
Measured: at 48 hours
Measurement of serum phosphate
Measurement of serum phosphate
Measured: at 72 hours
Cumulative volume of crystalloid administration
Cumulative volume of crystalloid administration
Measured: at 72 hours
Cumulative volume of colloid administration
Cumulative volume of colloid administration
Measured: at 72 hours
Cumulative dose of norepinephrine administration
Cumulative dose of norepinephrine administration
Measured: at 72 hours
Duration of norepinephrine administration
Duration of norepinephrine administration
Measured: at 72 hours
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: at day 30
30-day mortality
30-day mortality
Measured: at day 30
Length of stay in intensive care
Length of stay in intensive care
Measured: at day 30
Length of stay at the hospital
Length of stay at the hospital
Measured: at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start26 Sep 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CongestionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Pilot, Controlled, Open-Label, Randomized Study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799910
- Sponsor's protocol ID
- PI2022_843_0069
- Acronym
- OBHIMER
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
- ClinicalTrials.gov ID
- NCT06799910
- Acronym / sponsor ID
- OBHIMER / PI2022_843_0069
- Conditions
- Congestion, RRT, UF, Bio-impendance Analysis, Fluid Removal, Diuretics
- Keywords
- bio-impendance analysis, fluid removal, diuretics, overload, congestion, RRT, UF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. When diuretics fail, RRT, typically through continuous renal replacement therapy (CRRT), is recommended. However, prescribing the correct level of UF is challenging; insufficient UF can worsen edema, while excessive UF risks hemodynamic instability. This pilot, single-center, prospective, interventional, randomized, controlled, open-label study includes two parallel groups: a standard group with UF prescribed by the physician based on clinical and hemodynamic status and an experimental group with UF guided by the extracellular to total body water (ECW/TBWat) ratio measured by BIA. The aim is to determine if ECW/TBW-guided UF improves fluid and TBW reduction over a 72-hour RRT period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Pilot, Controlled, Open-Label, Randomized Study
| Arm | Type | Receives |
|---|---|---|
| Free UF Prescription | Active comparator | Procedure: continuous renal replacement therapy (CRRT)Free UF Prescription : The UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition. |
| UF Prescription Guided by the ECW/TBWat Ratio | Experimental | Other: Free UF PrescriptionExperimental Group - UF Prescription Guided by the ECW/TBWat Ratio : * In the experimental group, the patient will receive a prescription for UF guided by the ECW/TBWat ratio. The goal is to achieve an ECW/TBWat ratio of less than 0.400 by the end of the 72-hour RRT session. * To meet this objective, the physician must measure the ECW/TBWat ratio each time the UF is adjusted. If the patient's ECW/TBWat ratio is less than 0.400 at the measurement time, the goal is to maintain it below 0.400 during the RRT session. * To calculate the ECW/TBWATratio, the Inbody BWA 2.0 device requires the initial TBW, which will be measured by the Hill-Room Acella 900 bed (Hill-Room, Batesville, USA). * The ratio is calculated by the Inbody BWA 2.0 and is based on the average of 3 consecutive measurements. * The physician determines the prescription for adjusting the UF (ml/h) based on the patient's hemodynamic and clinical condition during the RRT session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- The patient was hospitalized in the intensive care unit of Amiens-Picardie University Hospital.
- Patient with an increase in fluid balance (TBW > 5%)
- Patient receiving continuous veno-venous hemofiltration (CVVH) on a PrismaFlexR or PrisMaxR machine, initiated due to oliguria, potassium level > 6.5 mmol/L, urea level > 25 mmol/L, or creatinine > 300 µmol/L and severe metabolic acidosis (pH < 7.2).
- Hemodynamically stable patient with a mean arterial pressure (MAP) > 65 mmHg for more than 4 hours with norepinephrine.
Key exclusion criteria (9 listed)
- Invalid BIA measurements
- Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
- Cardiac arrhythmia (atrial fibrillation, atrial flutter) present at the inclusion
- Chronic dialysis patient
- Moribund patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous renal replacement therapy (CRRT)The patient is included in the study once they meet the eligibility criteria and as soon as the responsible physician has prescribed RRT according to the department's protocol. Randomization will be performed, and the patient will be assigned to either the standard or experimental groups. | Procedure or surgery | Free UF Prescription |
| Free UF PrescriptionThe UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition. | Other | UF Prescription Guided by the ECW/TBWat Ratio |
Primary outcome
comparison of TBW between both groups
Time frame: at 72 hours
To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.
35 secondary outcomes
Variation of cumulative net UF
Time frame: at 72 hours
Measurement of the net UF rate
Time frame: at 72 hours
Measurement of the ECW/TBWATratio and its association with the VeXUS score
Time frame: day 0
Measurement of the ECW/TBWATratio and its association with the VeXUS score
Time frame: at 72 hours
Measurement of the ECW/TBWAT ratio
Time frame: day 0
Measurement of the ECW/TBWAT ratio
Time frame: 72 hours
number of filters used in both groups
Time frame: at 24 hours
number of filters used in both groups
Time frame: at 48 hours
number of filters used in both groups
Time frame: at 72 hours
duration of use for each filter in both groups
Time frame: at 24 hours
duration of use for each filter in both groups
Time frame: at 48 hours
duration of use for each filter in both groups
Time frame: at 72 hours
Number of hypotensive episodes during dialysis
Time frame: at 24 hours
Number of hypotensive episodes during dialysis
Time frame: at 48 hours
Number of hypotensive episodes during dialysis
Time frame: at 72 hours
Number of arrhythmias in both groups
Time frame: at 24 hours
Number of arrhythmias in both groups
Time frame: at 48 hours
Number of arrhythmias in both groups
Time frame: at 72 hours
Number of arrhythmias with hemodynamic instability
Time frame: at 24 hours
Number of arrhythmias with hemodynamic instability
Time frame: at 48 hours
Number of arrhythmias with hemodynamic instability
Time frame: at 72 hours
Measurement of serum potassium
Time frame: at 24 hours
Measurement of serum potassium
Time frame: at 48 hours
Measurement of serum potassium
Time frame: at 72 hours
Measurement of serum phosphate
Time frame: at 24 hours
Measurement of serum phosphate
Time frame: at 48 hours
Measurement of serum phosphate
Time frame: at 72 hours
Cumulative volume of crystalloid administration
Time frame: at 72 hours
Cumulative volume of colloid administration
Time frame: at 72 hours
Cumulative dose of norepinephrine administration
Time frame: at 72 hours
Duration of norepinephrine administration
Time frame: at 72 hours
Duration of mechanical ventilation
Time frame: at day 30
30-day mortality
Time frame: at day 30
Length of stay in intensive care
Time frame: at day 30
Length of stay at the hospital
Time frame: at day 30
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous renal replacement therapy (CRRT) and Free UF Prescription in people with Congestion and RRT, run by Centre Hospitalier Universitaire, Amiens 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 6 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 29 Jan 2025. 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 Christophe Beyls, MD (33 + 03 22 08 78 66, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of TBW between both groups (time frame: at 72 hours). 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 29 Jan 2025.