Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

NCT04801784 | Completed

• 2 other identifiers: 69HCL20_12432021-A00692-39
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials. The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.

Conditions

Fluid Overload

Keywords

Fluid Overload; fluid balance; continuous renal replacement therapy; net ultrafiltration; acute kidney injury; hemodynamic monitoring; preload dependence; hemodynamic instability; acute circulatory failure; shock; deresuscitation

Outcome Measures

Primary Outcomes (1)

• Cumulative fluid balance

  The cumulative fluid balance (in ml) will be calculated as the total amount of input received by the patients (including IV fluids and medications, blood products, hydration and nutrition), minus the total output over the same period of time (including urine output, net ultrafiltration, and drains). The cumulative fluid balance at H72 will be compared between study groups in alive patients at H72.

  72 hours from study inclusion (H72)

Secondary Outcomes (16)

• Number of hemodynamic episodes

  72 hours from study inclusion

• Number of hemodynamic episodes with preload dependence status

  72 hours from study inclusion

• Number of Major Adverse Kidney Events (MAKE)

  90 days from study inclusion

• Mean arterial pressure

  Every 4 hours from inclusion to 72 hours after inclusion

• Cardiac index

  Every 4 hours from inclusion to 72 hours after inclusion

Study Arms (2)

Fluid balance neutralization

EXPERIMENTAL

Fluid balance neutralization using increased net ultrafiltration, aiming to neutralize the cumulative fluid input received over the first 72 hours of study participation.

Procedure: Increased net ultrafiltration with advanced hemodynamic monitoring

Standard care

ACTIVE COMPARATOR

Active control group of positive fluid balance during the first 72 hours of study participation with zero or near-zero net ultrafiltration.

Procedure: Zero or near-zero net ultrafiltration

Interventions

Increased net ultrafiltration with advanced hemodynamic monitoring PROCEDURE

A net ultrafiltration rate of 100 ml/h or more will be applied during the first 72 hours of study participation. To insure the hemodynamic security of the intervention, it is associated with an advanced hemodynamic monitoring protocol which encompasses cardiac index, preload dependence assessment (using postural maneuvers), lactate levels and central venous pressure evaluation. The hemodynamic monitoring protocol allows the decrease or suspension of the neutral ultrafiltration rate in case of hemodynamic instability or of hemodynamic status considered at risk of worsening if net ultrafiltration rate is maintained.

Fluid balance neutralization

Zero or near-zero net ultrafiltration PROCEDURE

The active control group aims to represent the present standard of care of net ultrafiltration management in the first 72 hours of study participation in patients with critical illness. This will be performed by setting the net ultrafiltration rate to 0 up to 25 ml/h.

Standard care

Eligibility Criteria

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

You may qualify if:

• Patient 18 yo or more, affiliated to a social security system
• Treated with vasopressors for acute circulatory failure
• With KDIGO stage 3 acute kidney injury
• Treated with continuous renal replacement therapy for less than 24 jours
• Monitored with a calibrated continuous cardiac output device

You may not qualify if:

• Treatment by ECMO (extracorporeal membrane oxygenation)
• Active hemorrhage necessitating transfusion
• Maintenance dialysis or renal graft recipient
• Switch to intermittent hemodialysis is scheduled in the next 72 hours
• Acute cerebral stroke complicated by coma and under mechanical ventilation
• Acute fulminant hepatitis
• Postural maneuver (passive leg raising or Trendelenburg) cannot be performed (amputation, inferior vena cava obstruction)
• Pregnancy or lactating
• Withdrawal or limitation of care
• Moribund patient
• Patient under protective measures/wardship
• Patient previously enrolled in the same study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Bitker L, Pradat P, Dupuis C, Klouche K, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in critically ill patients requiring continuous renal replacement therapy: study protocol of the GO NEUTRAL randomized controlled trial. Trials. 2022 Sep 22;23(1):798. doi: 10.1186/s13063-022-06735-6.

  PMID: 36138465 RESULT

MeSH Terms

Conditions

Edema; Acute Kidney Injury; Shock

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes

Study Officials

• Laurent BITKER

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation masking to staff performing result analyses
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: June 30, 2021
• Primary Completion: April 18, 2023
• Study Completion: July 14, 2023
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (1)