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

NCT ID: NCT06799910

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Free UF Prescription

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.

Group Type: ACTIVE_COMPARATOR

continuous renal replacement therapy (CRRT)

Intervention Type: 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.

UF Prescription Guided by the ECW/TBWat Ratio

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.

Group Type: EXPERIMENTAL

Free UF Prescription

Intervention Type: 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.

Interventions

continuous 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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Amiens

Salouël, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe Beyls, MD

Role: CONTACT

beyls.christophe@chu-amiens.fr

33 + 03 22 08 78 66

Facility Contacts

Christophe Beyls, MD

Role: primary

beyls.christophe@chu-amiens.fr

33 + 03 22 08 78 66

Other Identifiers

PI2022_843_0069

Identifier Type: -

Identifier Source: org_study_id