Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06799910

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-01-29

60

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Hospitalized in the intensive care unit of Amiens-Picardie University Hospital
  • Increased fluid balance (total body water greater than 5%)
  • Receiving continuous veno-venous hemofiltration (CVVH) on PrismaFlexR or PrisMaxR machine due to oliguria, high potassium, high urea, high creatinine, or severe metabolic acidosis
  • Hemodynamically stable with mean arterial pressure over 65 mmHg for more than 4 hours with norepinephrine
  • Signed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Invalid bioelectrical impedance analysis measurements
  • Presence of internal electrical devices like pacemaker or neurostimulator
  • Cardiac arrhythmia such as atrial fibrillation or flutter at inclusion
  • Chronic dialysis patient
  • Moribund patient
  • On extracorporeal mechanical support
  • Experiencing hemorrhagic shock
  • Pregnant woman
  • Patient under guardianship or conservatorship

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHRU Amiens

Salouël, France, 80480

Actively Recruiting

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Research Team

C

Christophe Beyls, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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