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

NCT06799910 | Recruiting

• 1 other identifier: PI2022_843_0069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

bio-impendance analysis; fluid removal; diuretics; overload; congestion; RRT; UF

Outcome Measures

Primary Outcomes (1)

• comparison of TBW between both groups

  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.

  at 72 hours

Secondary Outcomes (35)

• Variation of cumulative net UF

  at 72 hours

• Measurement of the net UF rate

  at 72 hours

• 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 72 hours

• Measurement of the ECW/TBWAT ratio

  day 0

Study Arms (2)

Free UF Prescription

ACTIVE COMPARATOR

Free 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.

Procedure: continuous renal replacement therapy (CRRT)

UF Prescription Guided by the ECW/TBWat Ratio

EXPERIMENTAL

Experimental Group - UF Prescription Guided by the ECW/TBWat Ratio : * In the experimental group, the patient will receive a prescription for UF guided by the ECW/TBWat ratio. The goal is to achieve an ECW/TBWat ratio of less than 0.400 by the end of the 72-hour RRT session. * To meet this objective, the physician must measure the ECW/TBWat ratio each time the UF is adjusted. If the patient's ECW/TBWat ratio is less than 0.400 at the measurement time, the goal is to maintain it below 0.400 during the RRT session. * To calculate the ECW/TBWATratio, the Inbody BWA 2.0 device requires the initial TBW, which will be measured by the Hill-Room Acella 900 bed (Hill-Room, Batesville, USA). * The ratio is calculated by the Inbody BWA 2.0 and is based on the average of 3 consecutive measurements. * The physician determines the prescription for adjusting the UF (ml/h) based on the patient's hemodynamic and clinical condition during the RRT session.

Other: Free UF Prescription

Interventions

continuous renal replacement therapy (CRRT) PROCEDURE

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.

Free UF Prescription

Free UF Prescription OTHER

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.

UF Prescription Guided by the ECW/TBWat Ratio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Invalid BIA measurements
• Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
• Chronic dialysis patient
• Moribund patient
• The patient is on extracorporeal mechanical support
• Hemorrhagic shock
• Pregnant woman
• Patient under guardianship or conservators.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Salouël, 80480, France

RECRUITING

MeSH Terms

Interventions

Continuous Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Christophe Beyls, MD

CONTACT

33 + 03 22 08 78 66; beyls.christophe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Pilot, Controlled, Open-Label, Randomized Study

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 29, 2025
• Study Start: September 26, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)