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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
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.
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.
CHRU Amiens
Salouël, France
RECRUITINGcomparison 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.
Time frame: at 72 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 72 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Time frame: at 24 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Time frame: at 48 hours
number of filters used in both groups
Reporting of complications related to RRT in both groups : number of filters used
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 72 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Time frame: at 24 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Time frame: at 48 hours
Number of arrhythmias in both groups
Number of arrhythmias in both groups
Time frame: at 72 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Time frame: at 24 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Time frame: at 48 hours
Number of arrhythmias with hemodynamic instability
Number of arrhythmias with hemodynamic instability
Time frame: at 72 hours
Measurement of serum potassium
Measurement of serum potassium
Time frame: at 24 hours
Measurement of serum potassium
Measurement of serum potassium
Time frame: at 48 hours
Measurement of serum potassium
Measurement of serum potassium
Time frame: at 72 hours
Measurement of serum phosphate
Measurement of serum phosphate
Time frame: at 24 hours
Measurement of serum phosphate
Measurement of serum phosphate
Time frame: at 48 hours
Measurement of serum phosphate
Measurement of serum phosphate
Time frame: at 72 hours
Cumulative volume of crystalloid administration
Cumulative volume of crystalloid administration
Time frame: at 72 hours
Cumulative volume of colloid administration
Cumulative volume of colloid administration
Time frame: at 72 hours
Cumulative dose of norepinephrine administration
Cumulative dose of norepinephrine administration
Time frame: at 72 hours
Duration of norepinephrine administration
Duration of norepinephrine administration
Time frame: at 72 hours
Duration of mechanical ventilation
Duration of mechanical ventilation
Time frame: at day 30
30-day mortality
30-day mortality
Time frame: at day 30
Length of stay in intensive care
Length of stay in intensive care
Time frame: at day 30
Length of stay at the hospital
Length of stay at the hospital
Time frame: at day 30
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