Acute Kidney Injury, Fluid Overload
Conditions
Keywords
Renal Replacement Therapy (RRT), Ultrafiltration, Deresuscitation, Fluid balance, Fluid overload, Tissue perfusion
Brief summary
In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality. Patients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions. In usual practice, UF net prescription are variable and there are different international recommendations. Some observational studies suggest that using a UFnet between 1 et 1.75 mL/kg/h in fluid overloaded patient decrease mortality. Fluid overload increases morbidity and mortality, particularly in RRT. Studies without RRT argue for an efficacy of management by decreasing the fluid overload .Cohort studies suggest to use a moderate UFnet instead of a low UFnet. Some data from studies on early versus late RRT that relate the fluid balance or correct the fluid overload during the early strategy argue for a beneficial effect of an early deresuscitation strategy Consequently, the impact of a moderate UFnet (to decrease the fluid overload) compared to a low UFnet (to stabilize the fluid overload) in a randomized interventional study could be assessed. The study hypothesis is that : an early fluid overload deresuscitation protocol with a high UFnet (2 ml/kg/h) targeting both the negativation of cumulated fluid balance to reach a dry weight and the maintenance of tissue perfusion. Compared to fluid overload deresuscitation protocol with a low UFnet (between 0 and 1 ml/kg/h) to reach a stabilization of cumulated fluid balance without monitoring the tissue perfusion. could improve overall, renal, hemodynamic and respiratory prognosis in fluid overloaded patients with renal replacement therapy in ICU
Interventions
PROCEDUREFluid balance negativation
During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion . When the patient's baseline body weight is reached the UF net will be settled to maintain it. In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion.
PROCEDUREBody weight Stabilization
During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance. In case of weight stabilisation failure ( variation \>3% after 24h), the UF net can be increased to 1,5 ml/kg/h, as long as high intakes require UFnette at 1.5mL/kg/h to stabilize water balance, with daily reassessment. In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
For this protocol, the double blind is impossible to set up. Clinicians in charge of patients and implementing the depletion strategy cannot be blinded. The patients will be blinded, they will not be aware of strategy applied. The medical staff will ensure that no information about the intervention is given to the patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days, 2. At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or oxygen therapy or vascular filling \> 1000ml or vasopressor exposure \> 12 hours), 3. Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion, 4. Norepinephrine \< 0,5 µg/kg/min, 5. Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria: * TRC \> 3s at the finger * Marbrure score \> 2 * Lactate \> 2 mmol/L * ScVO2\< 60%, 6. Fluid overload defined as follows : * fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or * Obvious oedema of the lumbar region or flanks (oedema \> 1cm bucket depth).
Exclusion criteria
1. Chronic renal failure hemodialyzed before admission to the ICU, 2. Mechanical circulatory support (ECMO, LVAD), 3. Pregnant, child -bearing age or lactating women, 4. Stroke based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less than 30 days, 5. Intestinal ischemia less than 7 days documented non-operated, 6. Interventional study participation or exclusion period on going,that may interfere with the present study 7. Guardianship, curatorship or safeguard of justice, 8. Absence of signature of free and informed consent by the patient and/or relative, 9. Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of organ replacement free-days | Day 30 | Number of organ replacement free-days, i.e, number of renal replacement therapy-free days, number of vasopressor-free days, number of ventilator-free day. Number of days between 2 same type organ replacement interruption is not counted. In case of death before 30 days, number of days is censored to 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality decrease | 30 days | Number of deaths |
| Number of renal replacement therapy-free days increase | Day 30 | Number of renal replacement therapy-free days |
| Number of ventilator-free day increase | Day 30 | Number of ventilator-free day |
| Number of vasopressor-free day increase | Day 30 | Number of vasopressor-free day |
| Duration of intensive care unit stay | Up to Day 30 | Number of days in ICU |
| SOFA score evolution | From Day 0 up to Day 5 | SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse) |
| Incidence of arrhythmias and cardiac conduction disorders in both group | From Day 0 up to Day 5 | Number of arrhythmias and cardiac conduction disorders occurrence on ECG |
| Incidence of intestinal ischemia in both group | From Day 0 to Day 30 | Number of intestinal ischemia on CT scan or endoscopy |
| Incidence of strokes | From Day 0 to Day 30 | Number of ischemic strokes occurrence on imagery |
| Incidence of delirium | Between Day 0 and Day 5 | Presence of delirium assessed with the CAM ICU scale : positive or negative score. A positive score means presence of delirium |
| Renal recovery assessment | Day 30 | Renal recovery is defined according to MAKE 30 scale : * Survival * Absence of renal replacement therapy * Day 30 creatinine level \< baseline creatinine x 200 % |
Countries
France
Contacts
Primary ContactMatthias JACQUET LAGREZE, MD PhD
Backup ContactJulia CANTERINI, project manager
Outcome results
None listed