Clinical trial NCT04801784: Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)
Official title: Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Cumulative fluid balance
timeFrame: 72 hours from study inclusion (H72)
Secondary outcomes:
measure: Number of hemodynamic episodes
timeFrame: 72 hours from study inclusion
measure: Number of hemodynamic episodes with preload dependence status
timeFrame: 72 hours from study inclusion
measure: Number of Major Adverse Kidney Events (MAKE)
timeFrame: 90 days from study inclusion
measure: Mean arterial pressure
timeFrame: Every 4 hours from inclusion to 72 hours after inclusion
measure: Cardiac index
timeFrame: Every 4 hours from inclusion to 72 hours after inclusion
measure: Lactatemia
timeFrame: Every 4 hours from inclusion to 72 hours after inclusion
measure: Vasopressor dose administered
timeFrame: Every 4 hours from inclusion to 72 hours after inclusion
measure: Cumulative fluid balance
timeFrame: 24 hours and day 7 from study inclusion
measure: Cumulative net ultrafiltration
timeFrame: 24 hours, 72 hours and day 7 from study inclusion
measure: Number of respiratory and circulatory failure free days
timeFrame: Day 28 of study inclusion
measure: Severity of organ failures using the SOFA score
timeFrame: from inclusion to 72 hours of study inclusion
measure: PaO2/FiO2 ratio
timeFrame: 24 hours, 48 hours, and 72 hours from study inclusion
measure: Extravascular lung water index
timeFrame: 24 hours, 48 hours, and 72 hours from study inclusion
measure: Hospitalisation duration
timeFrame: Day 90 of study inclusion
measure: Duration of stay in Intensive Care Unit (ICU)
timeFrame: Day 90 of study inclusion
measure: Survival
timeFrame: Day 28 and 90 of study inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Laurent BITKER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.