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NCT Number: NCT06799910

Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care

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.

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Key information

Conditions

Congestion Bio-impendance Analysis Diuretics Fluid Removal Overload RRT UF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Salouël, 80480, France

Location status: Recruiting

Location contact

Christophe Beyls, MD

CONTACT

[email protected]

33 + 03 22 08 78 66

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Hemorrhagic shock
  • Pregnant woman
  • Patient under guardianship or conservators.

Treatment and study plan

continuous renal replacement therapy (CRRT)

Procedure

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 Prescription

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Variation of cumulative net UF

    Time frame: at 72 hours

    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.

  2. Measurement of the net UF rate

    Time frame: at 72 hours

    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.

  3. 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 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.

  4. Measurement of the ECW/TBWATratio and its association with the VeXUS score

    Time frame: at 72 hours

    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.

  5. Measurement of the ECW/TBWAT ratio

    Time frame: day 0

    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).

  6. Measurement of the ECW/TBWAT ratio

    Time frame: 72 hours

    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).

  7. number of filters used in both groups

    Time frame: at 24 hours

    Reporting of complications related to RRT in both groups : number of filters used

  8. number of filters used in both groups

    Time frame: at 48 hours

    Reporting of complications related to RRT in both groups : number of filters used

  9. number of filters used in both groups

    Time frame: at 72 hours

    Reporting of complications related to RRT in both groups : number of filters used

  10. duration of use for each filter in both groups

    Time frame: at 24 hours

    complications related to RRT in both groups : duration of use for each filter in both groups

  11. duration of use for each filter in both groups

    Time frame: at 48 hours

    complications related to RRT in both groups : duration of use for each filter in both groups

  12. duration of use for each filter in both groups

    Time frame: at 72 hours

    complications related to RRT in both groups : duration of use for each filter in both groups

  13. Number of hypotensive episodes during dialysis

    Time frame: at 24 hours

    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

  14. Number of hypotensive episodes during dialysis

    Time frame: at 48 hours

    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

  15. Number of hypotensive episodes during dialysis

    Time frame: at 72 hours

    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

  16. Number of arrhythmias in both groups

    Time frame: at 24 hours

    Number of arrhythmias in both groups

  17. Number of arrhythmias in both groups

    Time frame: at 48 hours

    Number of arrhythmias in both groups

  18. Number of arrhythmias in both groups

    Time frame: at 72 hours

    Number of arrhythmias in both groups

  19. Number of arrhythmias with hemodynamic instability

    Time frame: at 24 hours

    Number of arrhythmias with hemodynamic instability

  20. Number of arrhythmias with hemodynamic instability

    Time frame: at 48 hours

    Number of arrhythmias with hemodynamic instability

  21. Number of arrhythmias with hemodynamic instability

    Time frame: at 72 hours

    Number of arrhythmias with hemodynamic instability

  22. Measurement of serum potassium

    Time frame: at 24 hours

    Measurement of serum potassium

  23. Measurement of serum potassium

    Time frame: at 48 hours

    Measurement of serum potassium

  24. Measurement of serum potassium

    Time frame: at 72 hours

    Measurement of serum potassium

  25. Measurement of serum phosphate

    Time frame: at 24 hours

    Measurement of serum phosphate

  26. Measurement of serum phosphate

    Time frame: at 48 hours

    Measurement of serum phosphate

  27. Measurement of serum phosphate

    Time frame: at 72 hours

    Measurement of serum phosphate

  28. Cumulative volume of crystalloid administration

    Time frame: at 72 hours

    Cumulative volume of crystalloid administration

  29. Cumulative volume of colloid administration

    Time frame: at 72 hours

    Cumulative volume of colloid administration

  30. Cumulative dose of norepinephrine administration

    Time frame: at 72 hours

    Cumulative dose of norepinephrine administration

  31. Duration of norepinephrine administration

    Time frame: at 72 hours

    Duration of norepinephrine administration

  32. Duration of mechanical ventilation

    Time frame: at day 30

    Duration of mechanical ventilation

  33. 30-day mortality

    Time frame: at day 30

    30-day mortality

  34. Length of stay in intensive care

    Time frame: at day 30

    Length of stay in intensive care

  35. Length of stay at the hospital

    Time frame: at day 30

    Length of stay at the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD

CONTACT

[email protected]

33 + 03 22 08 78 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: OBHIMER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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