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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corrective strategy | Experimental | In the experimental group, all patients will have a UFnet settled (2 ml/kg/h ) in order to reach the patient baseline body weight. |
|
| Stabilizing strategy | Other | In the control group, all patients will have a UFnet 2 ml settled (0 to 1 ml/kg/h) in order to stabilize the patient body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid balance negativation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of organ replacement free-days | 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. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality decrease | Number of deaths | 30 days |
| Number of renal replacement therapy-free days increase | Number of renal replacement therapy-free days |
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Inclusion Criteria:
Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
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),
Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion,
Norepinephrine < 0,5 µg/kg/min,
Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria:
Fluid overload defined as follows :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias JACQUET LAGREZE, MD PhD | Contact | 04 72 35 79 41 | +33 | Matthias.jacquet-lagreze@chu-lyon.fr |
| Julia CANTERINI, project manager | Contact | 04 27 85 66 28 | +33 | Julia.canterini@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Ajaccio | Not yet recruiting | Ajaccio | 20090 | France |
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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.
|
| Body weight Stabilization | Procedure | 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. |
|
| Day 30 |
| Number of ventilator-free day increase | Number of ventilator-free day | Day 30 |
| Number of vasopressor-free day increase | Number of vasopressor-free day | Day 30 |
| Duration of intensive care unit stay | Number of days in ICU | Up to Day 30 |
| SOFA score evolution | SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse) | From Day 0 up to Day 5 |
| Incidence of arrhythmias and cardiac conduction disorders in both group | Number of arrhythmias and cardiac conduction disorders occurrence on ECG | From Day 0 up to Day 5 |
| Incidence of intestinal ischemia in both group | Number of intestinal ischemia on CT scan or endoscopy | From Day 0 to Day 30 |
| Incidence of strokes | Number of ischemic strokes occurrence on imagery | From Day 0 to Day 30 |
| Incidence of delirium | Presence of delirium assessed with the CAM ICU scale : positive or negative score. A positive score means presence of delirium | Between Day 0 and Day 5 |
| Renal recovery assessment | Renal recovery is defined according to MAKE 30 scale :
| Day 30 |
| CHU Amiens-Picardie | Not yet recruiting | Amiens | 80480 | France |
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| Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon | Recruiting | Bron | 69500 | France |
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| CHU Caen Normandie | Not yet recruiting | Caen | 14033 | France |
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| Service de Réanimation, CHU de Dijon | Recruiting | Dijon | 21000 | France |
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| GHP Saint Joseph Marie Lannelongue | Not yet recruiting | Le Plessis-Robinson | 92350 | France |
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| CHU Lille - Hôpital Roger Salengro | Not yet recruiting | Lille | 59037 | France |
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| Hôpital Edouard Herriot, Groupement Hospitalier Centre | Recruiting | Lyon | 69003 | France |
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| Hôpital de la Croix Rousse | Not yet recruiting | Lyon | 69004 | France |
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| Hôpital de la Croix Rousse | Recruiting | Lyon | 69004 | France |
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| Service de Réanimation, Clinique de la Sauvegarde | Recruiting | Lyon | 69009 | France |
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| Hôpital Edouard Herriot | Not yet recruiting | Lyon | 69437 | France |
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| Département d'anesthésie réanimation Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| Hôpitaux de Bradois - CHRU Nancy | Not yet recruiting | Vandœuvre-lès-Nancy | 54511 | France |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D004487 | Edema |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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