Bio-impendance Analysis, Congestion, Diuretics, Fluid Removal, Overload, RRT, UF
Conditions
Keywords
bio-impendance analysis, fluid removal, diuretics, overload, congestion, RRT, UF
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.
Interventions
PROCEDUREcontinuous renal replacement therapy (CRRT)
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.
OTHERFree UF Prescription
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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A Pilot, Controlled, Open-Label, Randomized Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Measurement of the ECW/TBWATratio and its association with the VeXUS score | 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. |
| Measurement of the ECW/TBWAT ratio | 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). |
| number of filters used in both groups | at 24 hours | Reporting of complications related to RRT in both groups : number of filters used |
| duration of use for each filter in both groups | at 24 hours | complications related to RRT in both groups : duration of use for each filter in both groups |
| Number of hypotensive episodes during dialysis | 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 |
| Number of arrhythmias in both groups | at 24 hours | Number of arrhythmias in both groups |
| Number of arrhythmias with hemodynamic instability | at 24 hours | Number of arrhythmias with hemodynamic instability |
| Measurement of serum potassium | at 24 hours | Measurement of serum potassium |
| 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. |
| Cumulative volume of crystalloid administration | at 72 hours | Cumulative volume of crystalloid administration |
| Cumulative volume of colloid administration | at 72 hours | Cumulative volume of colloid administration |
| Cumulative dose of norepinephrine administration | at 72 hours | Cumulative dose of norepinephrine administration |
| Duration of norepinephrine administration | at 72 hours | Duration of norepinephrine administration |
| Duration of mechanical ventilation | at day 30 | Duration of mechanical ventilation |
| 30-day mortality | at day 30 | 30-day mortality |
| Length of stay in intensive care | at day 30 | Length of stay in intensive care |
| Length of stay at the hospital | at day 30 | Length of stay at the hospital |
| Measurement of serum phosphate | at 24 hours | Measurement of serum phosphate |
Countries
France
Contacts
Primary ContactChristophe Beyls, MD
Outcome results
None listed