Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
NCT ID: NCT05817539
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-12-15
2028-01-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
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.
Study Groups
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Corrective strategy
In the experimental group, all patients will have a UFnet settled (2 ml/kg/h ) in order to reach the patient baseline body weight.
Fluid 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.
Stabilizing strategy
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.
Body 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.
Interventions
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Fluid 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.
Body 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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Centre Hospitalier d'Ajaccio
Ajaccio, , France
CHU Amiens-Picardie
Amiens, , France
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, , France
CHU Caen Normandie
Caen, , France
Service de Réanimation, CHU de Dijon
Dijon, , France
GHP Saint Joseph Marie Lannelongue
Le Plessis-Robinson, , France
CHU Lille - Hôpital Roger Salengro
Lille, , France
Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
Service de Réanimation, Clinique de la Sauvegarde
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Département d'anesthésie réanimation Hôpital Européen Georges Pompidou
Paris, , France
Hôpitaux de Bradois - CHRU Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL22_1095
Identifier Type: -
Identifier Source: org_study_id
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