Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)
- Conditions
- Fluid Overload
- Interventions
- Procedure: Increased net ultrafiltration with advanced hemodynamic monitoringProcedure: Zero or near-zero net ultrafiltration
- Registration Number
- NCT04801784
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluid balance neutralization Increased net ultrafiltration with advanced hemodynamic monitoring Fluid balance neutralization using increased net ultrafiltration, aiming to neutralize the cumulative fluid input received over the first 72 hours of study participation. Standard care Zero or near-zero net ultrafiltration Active control group of positive fluid balance during the first 72 hours of study participation with zero or near-zero net ultrafiltration.
- Primary Outcome Measures
Name Time Method Cumulative fluid balance 72 hours from study inclusion (H72) 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.
- Secondary Outcome Measures
Name Time Method Lactatemia Every 4 hours from inclusion to 72 hours after inclusion Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Severity of organ failures using the SOFA score from inclusion to 72 hours of study inclusion Organ failure severity is quantified using the SOFA score (Sepsis-related organ failure assessment), and is collected at inclusion, and daily until Hours 72. The SOFA score assesses 6 physiological systems: respiratory, circulatory, coagulation, liver, renal and neurological.
Mean arterial pressure Every 4 hours from inclusion to 72 hours after inclusion Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Duration of stay in Intensive Care Unit (ICU) Day 90 of study inclusion Duration of stay in ICU will be quantified as the delay between participant admission and discharge from ICU, censored at day 90 from inclusion
Cardiac index Every 4 hours from inclusion to 72 hours after inclusion Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Vasopressor dose administered Every 4 hours from inclusion to 72 hours after inclusion Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Hospitalisation duration Day 90 of study inclusion Hospitalisation duration will be quantified as the delay between participant admission and discharge from hospital, censored at day 90 from inclusion.
PaO2/FiO2 ratio 24 hours, 48 hours, and 72 hours from study inclusion Intensity of pulmonary hydrostatic edema will be quantified using the PaO2/FiO2 ratio variation from inclusion to Hours24, Hours48 and Hours72 of study inclusion
Number of hemodynamic episodes with preload dependence status 72 hours from study inclusion Hemodynamic episodes defined as stated above, that were associated with preload dependence, defined as a significant increase in cardiac index when performing a postural maneuver. This test will be performed every 4 hours as part of the hemodynamic protocol
Number of Major Adverse Kidney Events (MAKE) 90 days from study inclusion MAKE is a composite criterion applied to participants, composed of either the persistence of renal impairment at Day90 (defined as a serum creatinine \> 2 x baseline value), renal replacement therapy dependence at Day90, or death at Day90. A separate analysis of each components of the MAKE 90 outcome will be performed.
Cumulative net ultrafiltration 24 hours, 72 hours and day 7 from study inclusion The cumulative net ultrafiltration is reported by CRRT (continuous renal replacement therapy) generators ad collected every 4 hours from inclusion to 72 hours after inclusion.
Number of respiratory and circulatory failure free days Day 28 of study inclusion Organ failure free days are defined as the number of days without organ support, and censored at 28 days of inclusion. Weaning of mechanical ventilation is defined as being free of IMV for 48 hours or more. Weaning of vasopressor is defined as being free of any vasopressor administration for 48 hours or more. Participant who die are over the 28-day period are assigned a value of 0 organ failure free days.
Survival Day 28 and 90 of study inclusion Vital status (death/alive) will be reported at D28 and D90 of study inclusion.
Number of hemodynamic episodes 72 hours from study inclusion Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure \< 65 mm Hg and requiring urgent intervention, a decrease in cardiac index \> 15%, or tachycardia \> 120 beats per minute (bpm).
Cumulative fluid balance 24 hours and day 7 from study inclusion The cumulative fluid balance will be calculated as stated for the primary outcome at Hours24. It will be estimated using body weight variation between inclusion and day 7.
Extravascular lung water index 24 hours, 48 hours, and 72 hours from study inclusion Intensity of pulmonary hydrostatic edema will be quantified using the extravascular lung water index reported by the continuous cardiac monitoring device, from inclusion to Hours24, Hours48 and Hours72 of study inclusion
Trial Locations
- Locations (1)
Hospices Civils de Lyon - Hôpital de la Croix Rousse
🇫🇷Lyon, France