Fluid OverloadUF BIANCT05160467
Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy
An observational study of Fluid Overload, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload
- What is being tested?
- Segmental multi-frequency bio electrical impedance analysis
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with fluid overload (defined by a cumulative fluid balance > 5%), stable hemodynamic (defined by Norepinephrine equivalent < 0.5µg/kg/min and nor clinical nor biological sign of hypoperfusion) and continuous renal replacement therapy. All these patients benefit in our service from a protocol directed, perfusion based deresuscitation strategy with net ultra filtration to induce negative fluid balance.
Who may be able to join
- Age higher than 18
- Protocol directed deresucitation strategy with net ultrafiltration during continuous renal replacement therapy
- Bioelectrical impedance analysis available for the day of the initiation of the deresuscitation strategy and at day 5" -> "At least two bioelectrical impedance analysis available during the first 5 days of the initiation of the deresuscitation strategy".
Who cannot join
- Left ventricular assist device
- Patient opposition to the use of his health data
- Invalid bioelectrical impedance analysis
- Advanced directives to withhold or withdraw life-sustaining treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
Bron, 69500
Martin RUSTE, M.D Msc, +33472118956, martin.ruste@chu-lyon.fr
About this study
Official title: Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study
Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.
Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.
Read more
We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.
We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.
- Conditions
- Fluid Overload
- Being tested
- Segmental multi-frequency bio electrical impedance analysis
- Keywords
- bio electrical impedance analysis, fluid overload, deresuscitation strategy, net ultra filtration
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental multi-frequency bio electrical impedance analysisDiagnostic test
A segmental (eight-polar) multi-frequency bio electrical impedance analysis (Inbody S10, Seoul, Korea) is carried out at the initiation of the deresuscitation strategy, at day 1, 3 and 5, in lying posture with touch type electrodes. Raw and derived parameters are recorded. The measurement is performed 5 times for the first measurement and then one time at day 1, 3 and 5.
Measurement error is defined by the manufacturer as: reversed Impedance in different segment all between 5-500kHz; impedance over 50Ω in trunk, or over 700Ω in limb; sudden drop of impedance in trunk (more than 10Ω), or in limb (more than 50Ω). If it occurs, measurement is carried out three times maximum after solving potential technical issues to obtain a valid analysis.
| Study group | Role | What they receive |
|---|---|---|
| Deresuscitation cohort | Patients with fluid overload (defined by a cumulative fluid balance > 5%), stable hemodynamic (defined by Norepinephrine equivalent < 0.5µg/kg/min and nor clinical nor biological sign of hypoperfusion) and continuous renal replacement therapy. All these patients benefit in our service from a protocol directed, perfusion based deresuscitation strategy with a 2mL/kg/h net ultra filtration to induce negative fluid balance and correct fluid overload. If hypoperfusion occurs, the net ultra filtration is stopped; if pulmonary oedema or right ventricular dysfunction occurs, the net ultra filtration is set to 3mL/kg/h.
We carried out at day 0, 1,3 and 5 bio electrical impedance analysis with an eight polar multifrequency bio impedance monitor (InBody S10), and monitor cumulative fluid balance with our prescription software and daily weight assessment. Receives: Diagnostic Test: Segmental multi-frequency bio electrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between changes in extracellular water volume estimated by BIA and cumulative fluid balance between day 0 and day 5 (mL).
The extra cellular water is a volumetric value, given automatically by the InBody S10 device. The cumulative fluid balance at day 5 is the sum of the daily fluid balances between day 0 and day 5.
Definition of the fluid balance = inputs - outputs :
- Inputs = total cumulative volume of: parenteral medication; enteral and parenteral nutrition; maintenance fluid; blood products; fluid bolus therapy
- Outputs = total cumulative volume of: diuresis; losses to drain; net ultra filtration
Measured: Coefficient correlation between the variation from day 0 to day 5 of extra cellular water and cumulative fluid balance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Mar 2021
- Primary completion15 Nov 2021
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160467
- Sponsor's protocol ID
- 532
- Acronym
- UF BIA
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT05160467
- Acronym / sponsor ID
- UF BIA / 532
- Conditions
- Fluid Overload
- Keywords
- bio electrical impedance analysis, fluid overload, deresuscitation strategy, net ultra filtration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 16 Dec 2021 (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.
Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.
Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.
We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.
We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deresuscitation cohort | – | Diagnostic Test: Segmental multi-frequency bio electrical impedance analysisPatients with fluid overload (defined by a cumulative fluid balance > 5%), stable hemodynamic (defined by Norepinephrine equivalent < 0.5µg/kg/min and nor clinical nor biological sign of hypoperfusion) and continuous renal replacement therapy. All these patients benefit in our service from a protocol directed, perfusion based deresuscitation strategy with a 2mL/kg/h net ultra filtration to induce negative fluid balance and correct fluid overload. If hypoperfusion occurs, the net ultra filtration is stopped; if pulmonary oedema or right ventricular dysfunction occurs, the net ultra filtration is set to 3mL/kg/h. We carried out at day 0, 1,3 and 5 bio electrical impedance analysis with an eight polar multifrequency bio impedance monitor (InBody S10), and monitor cumulative fluid balance with our prescription software and daily weight assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fluid overload (defined by a cumulative fluid balance > 5%), stable hemodynamic (defined by Norepinephrine equivalent < 0.5µg/kg/min and nor clinical nor biological sign of hypoperfusion) and continuous renal replacement therapy. All these patients benefit in our service from a protocol directed, perfusion based deresuscitation strategy with net ultra filtration to induce negative fluid balance.
Key inclusion criteria (3 listed)
- Age higher than 18
- Protocol directed deresucitation strategy with net ultrafiltration during continuous renal replacement therapy
- Bioelectrical impedance analysis available for the day of the initiation of the deresuscitation strategy and at day 5" -> "At least two bioelectrical impedance analysis available during the first 5 days of the initiation of the deresuscitation strategy".
Key exclusion criteria (4 listed)
- Left ventricular assist device
- Patient opposition to the use of his health data
- Invalid bioelectrical impedance analysis
- Advanced directives to withhold or withdraw life-sustaining treatment
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 |
|---|---|---|
| Segmental multi-frequency bio electrical impedance analysisA segmental (eight-polar) multi-frequency bio electrical impedance analysis (Inbody S10, Seoul, Korea) is carried out at the initiation of the deresuscitation strategy, at day 1, 3 and 5, in lying posture with touch type electrodes. Raw and derived parameters are recorded. The measurement is performed 5 times for the first measurement and then one time at day 1, 3 and 5. Measurement error is defined by the manufacturer as: reversed Impedance in different segment all between 5-500kHz; impedance over 50Ω in trunk, or over 700Ω in limb; sudden drop of impedance in trunk (more than 10Ω), or in limb (more than 50Ω). If it occurs, measurement is carried out three times maximum after solving potential technical issues to obtain a valid analysis. | Diagnostic test | Deresuscitation cohort |
Primary outcome
Correlation coefficient between changes in extracellular water volume estimated by BIA and cumulative fluid balance between day 0 and day 5 (mL).
Time frame: Coefficient correlation between the variation from day 0 to day 5 of extra cellular water and cumulative fluid balance
The extra cellular water is a volumetric value, given automatically by the InBody S10 device. The cumulative fluid balance at day 5 is the sum of the daily fluid balances between day 0 and day 5. Definition of the fluid balance = inputs - outputs : * Inputs = total cumulative volume of: parenteral medication; enteral and parenteral nutrition; maintenance fluid; blood products; fluid bolus therapy * Outputs = total cumulative volume of: diuresis; losses to drain; net ultra filtration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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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. This study is not recruiting at the moment.
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 Fluid Overload, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin RUSTE, Dr (+33472118956, 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?
Correlation coefficient between changes in extracellular water volume estimated by BIA and cumulative fluid balance between day 0 and day 5 (mL). (time frame: Coefficient correlation between the variation from day 0 to day 5 of extra cellular water and cumulative fluid balance). 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 28 Jan 2022.