Clinical trial NCT06799910: Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
Official title: Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congestion
RRT
UF
Bio-impendance Analysis
Fluid Removal
Diuretics
Overload
Keywords: bio-impendance analysis
fluid removal
diuretics
overload
congestion
RRT
UF
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Pilot, Controlled, Open-Label, Randomized Study
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: comparison of TBW between both groups
timeFrame: at 72 hours
Secondary outcomes:
measure: Variation of cumulative net UF
timeFrame: at 72 hours
measure: Measurement of the net UF rate
timeFrame: at 72 hours
measure: Measurement of the ECW/TBWATratio and its association with the VeXUS score
timeFrame: day 0
measure: Measurement of the ECW/TBWATratio and its association with the VeXUS score
timeFrame: at 72 hours
measure: Measurement of the ECW/TBWAT ratio
timeFrame: day 0
measure: Measurement of the ECW/TBWAT ratio
timeFrame: 72 hours
measure: number of filters used in both groups
timeFrame: at 24 hours
measure: number of filters used in both groups
timeFrame: at 48 hours
measure: number of filters used in both groups
timeFrame: at 72 hours
measure: duration of use for each filter in both groups
timeFrame: at 24 hours
measure: duration of use for each filter in both groups
timeFrame: at 48 hours
measure: duration of use for each filter in both groups
timeFrame: at 72 hours
measure: Number of hypotensive episodes during dialysis
timeFrame: at 24 hours
measure: Number of hypotensive episodes during dialysis
timeFrame: at 48 hours
measure: Number of hypotensive episodes during dialysis
timeFrame: at 72 hours
measure: Number of arrhythmias in both groups
timeFrame: at 24 hours
measure: Number of arrhythmias in both groups
timeFrame: at 48 hours
measure: Number of arrhythmias in both groups
timeFrame: at 72 hours
measure: Number of arrhythmias with hemodynamic instability
timeFrame: at 24 hours
measure: Number of arrhythmias with hemodynamic instability
timeFrame: at 48 hours
measure: Number of arrhythmias with hemodynamic instability
timeFrame: at 72 hours
measure: Measurement of serum potassium
timeFrame: at 24 hours
measure: Measurement of serum potassium
timeFrame: at 48 hours
measure: Measurement of serum potassium
timeFrame: at 72 hours
measure: Measurement of serum phosphate
timeFrame: at 24 hours
measure: Measurement of serum phosphate
timeFrame: at 48 hours
measure: Measurement of serum phosphate
timeFrame: at 72 hours
measure: Cumulative volume of crystalloid administration
timeFrame: at 72 hours
measure: Cumulative volume of colloid administration
timeFrame: at 72 hours
measure: Cumulative dose of norepinephrine administration
timeFrame: at 72 hours
measure: Duration of norepinephrine administration
timeFrame: at 72 hours
measure: Duration of mechanical ventilation
timeFrame: at day 30
measure: 30-day mortality
timeFrame: at day 30
measure: Length of stay in intensive care
timeFrame: at day 30
measure: Length of stay at the hospital
timeFrame: at day 30
Other outcomes:
Locations:
city: Salouel
country: France
facility: CHRU Amiens
Study officials:
References: