Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06799910

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

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients in critical care who require continuous renal replacement therapy (CRRT) to manage fluid overload. The study aims to evaluate whether using bioelectrical impedance analysis (BIA) to guide fluid removal improves the reduction of total body water (TBW) compared to standard care. Excess fluid can cause organ problems and raise the risk of death, so finding the right fluid removal method is important. This is a pilot, randomized, controlled, open-label study comparing two approaches to fluid removal during a 72-hour CRRT period. Participants are randomly assigned to one of two groups. In the standard group, fluid removal rates are set by the physician based on clinical and hemodynamic assessments. In the experimental group, fluid removal is guided by the extracellular to total body water ratio (ECW/TBWat) measured by BIA, aiming to keep this ratio below 0.400 during treatment. Measurements are taken with specialized devices to calculate the ratio, and the physician adjusts fluid removal accordingly. This process continues throughout the 72-hour CRRT session. During the study, patients will receive CRRT and have their fluid balance monitored closely. Researchers will assess total body water levels, fluid removal rates, and various clinical parameters such as blood pressure stability, arrhythmias, and blood chemistry at multiple time points up to 72 hours. Outcomes like filter use, norepinephrine dosage, ventilation duration, mortality, and hospital stay length will also be recorded. Patient safety and fluid status will be carefully tracked to compare the two fluid removal strategies over the treatment period.

CONDITIONS

Brief 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 over 18 years
  • Hospitalized in the intensive care unit of Amiens-Picardie University Hospital
  • Increased fluid balance with total body water over 5%
  • Receiving continuous veno-venous hemofiltration (CVVH) due to specific kidney or metabolic conditions
  • Hemodynamically stable with mean arterial pressure above 65 mmHg for more than 4 hours while on norepinephrine
  • Signed consent to participate by patient or legal representative
Not Eligible

You will not qualify if you...

  • Invalid bioelectrical impedance analysis (BIA) measurements
  • Presence of internal electrical devices like pacemaker or defibrillator
  • Cardiac arrhythmia such as atrial fibrillation or flutter at the time of inclusion
  • Chronic dialysis patient
  • Moribund (near death) patient
  • On extracorporeal mechanical support
  • Hemorrhagic shock
  • Pregnant woman
  • Patient under guardianship or conservatorship

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 72 hours

Participants undergo continuous renal replacement therapy (CRRT) with fluid removal prescribed either freely by the physician or guided by the ECW/TBW ratio to optimize fluid balance during a 72-hour session.

Continuous monitoring during treatment

Follow-up

Duration - Up to 30 days

Participants' clinical outcomes including safety measures and survival are assessed up to 30 days after treatment.

Assessments at day 30

Trial Site Locations

Total: 1 location

1

CHRU Amiens

Salouël, France, 80480

Actively Recruiting

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Research Team

C

Christophe Beyls, MD

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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