Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy) (GO-NEUTRAL)

Civil Hospices of Lyon

Status: Completed

Conditions: Fluid Overload

Treatments: Procedure: Zero or near-zero net ultrafiltration; Procedure: Increased net ultrafiltration with advanced hemodynamic monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04801784

69HCL20_1243

2021-A00692-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Fluid balance neutralization

Experimental group

Description:

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

Treatment:

Procedure: Increased net ultrafiltration with advanced hemodynamic monitoring

Standard care

Active Comparator group

Description:

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

Treatment:

Procedure: Zero or near-zero net ultrafiltration