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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • continuous renal replacement therapy (CRRT)

    Procedure/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 Prescription

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Free UF PrescriptionActive comparator 1 intervention
Group B: UF Prescription Guided by the ECW/TBWat RatioExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 72 hours

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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