NCT04801784

Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-04-18
• Completion: 2023-07-14
• First posted: 2021-03-17
• Last updated: 2025-11-21

Locations

1 site across 1 country: France