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

Not Applicable

Recruiting

• Conditions: Diuretics; Overload; Congestion; RRT; UF; Bio-impendance Analysis; Fluid Removal

• Registration Number: NCT06799910
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-26
• Study First Submitted: 2024-11-12
• Status Verified: 2024-12
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-05
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
comparison of TBW between both groups	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 Outcome Measures

Name	Time	Method
Measurement of the net UF rate	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.
Variation of cumulative net UF	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.
Measurement of the ECW/TBWATratio and its association with the VeXUS score	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.
Number of arrhythmias with hemodynamic instability	at 72 hours	Number of arrhythmias with hemodynamic instability
Duration of mechanical ventilation	at day 30	Duration of mechanical ventilation
Measurement of the ECW/TBWAT ratio	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).
number of filters used in both groups	at 72 hours	Reporting of complications related to RRT in both groups : number of filters used
duration of use for each filter in both groups	at 72 hours	complications related to RRT in both groups : duration of use for each filter in both groups
Measurement of serum phosphate	at 72 hours	Measurement of serum phosphate
Cumulative dose of norepinephrine administration	at 72 hours	Cumulative dose of norepinephrine administration
Length of stay at the hospital	at day 30	Length of stay at the hospital
Number of hypotensive episodes during dialysis	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
Number of arrhythmias in both groups	at 72 hours	Number of arrhythmias in both groups
Cumulative volume of colloid administration	at 72 hours	Cumulative volume of colloid administration
Duration of norepinephrine administration	at 72 hours	Duration of norepinephrine administration
Measurement of serum potassium	at 72 hours	Measurement of serum potassium
30-day mortality	at day 30	30-day mortality
Cumulative volume of crystalloid administration	at 72 hours	Cumulative volume of crystalloid administration
Length of stay in intensive care	at day 30	Length of stay in intensive care

Trial Locations

Locations (1)

CHRU Amiens; 🇫🇷 Salouel, France