Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

Hospices Civils de Lyon65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Fluid Overload

Interventions

Increased net ultrafiltration with advanced hemodynamic monitoringPROCEDURE

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.

Zero or near-zero net ultrafiltrationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, France

Outcomes

Primary Outcomes

Cumulative fluid balance

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.

Time frame: 72 hours from study inclusion (H72)

Secondary Outcomes

Number of hemodynamic episodes

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).

Time frame: 72 hours from study inclusion

Number of hemodynamic episodes with preload dependence status

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

Time frame: 72 hours from study inclusion

Number of Major Adverse Kidney Events (MAKE)

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.

Time frame: 90 days from study inclusion

Mean arterial pressure

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

Data from ClinicalTrials.gov

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