Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

NCT ID: NCT04801784

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-07-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Fluid balance neutralization

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

Group Type: EXPERIMENTAL

Increased net ultrafiltration with advanced hemodynamic monitoring

Intervention Type: 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.

Standard care

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

Group Type: ACTIVE_COMPARATOR

Zero or near-zero net ultrafiltration

Intervention Type: 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.

Interventions

Increased net ultrafiltration with advanced hemodynamic monitoring

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.

Intervention Type: PROCEDURE

Zero or near-zero net ultrafiltration

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Inclusion in another trial whose main outcome is cumulative fluid balance, or whose intervention targets hemodynamic physiology, fluid balance or net ultrafiltration.
• Patient previously enrolled in the same study

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

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent BITKER

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 36138465 (View on PubMed)

Other Identifiers

2021-A00692-39

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_1243

Identifier Type: -

Identifier Source: org_study_id