NCT06799910 Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
| NCT ID | NCT06799910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Congestion |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-26 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06799910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Congestion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06799910 currently recruiting?
Yes, NCT06799910 is actively recruiting participants. Contact the research team at beyls.christophe@chu-amiens.fr for enrollment information.
Where is the NCT06799910 trial being conducted?
This trial is being conducted at Salouël, France.
Who is sponsoring the NCT06799910 clinical trial?
NCT06799910 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 60 participants.