Clinical trial NCT05817539: Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Official title: Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure in Intensive Care Unit. A Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Fluid Overload
Keywords: Renal Replacement Therapy (RRT)
Ultrafiltration
Deresuscitation
Fluid balance
Fluid overload
Tissue perfusion
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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. Cumulative UF net less than 2000ml before inclusion,
4. Norepinephrine \< 0,5 µg/kg/min,
5. Absence of hypoperfusion signs,
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 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

Primary outcomes:
measure: Number of organ replacement free-days
timeFrame: Day 30
Secondary outcomes:
measure: Mortality decrease
timeFrame: 30 days
measure: Number of renal replacement therapy-free days increase
timeFrame: Day 30
measure: Number of ventilator-free day increase
timeFrame: Day 30
measure: Number of vasopressor-free day increase
timeFrame: Day 30
measure: Duration of intensive care unit stay
timeFrame: Up to Day 30
measure: SOFA score evolution
timeFrame: From Day 0 up to Day 5
measure: Incidence of arrhythmias and cardiac conduction disorders in both group
timeFrame: From Day 0 up to Day 5
measure: Incidence of intestinal ischemia in both group
timeFrame: From Day 0 to Day 30
measure: Incidence of strokes
timeFrame: From Day 0 to Day 30
measure: Incidence of delirium
timeFrame: Between Day 0 and Day 5
measure: Renal recovery assessment
timeFrame: Day 30
Other outcomes:
Locations:
city: Ajaccio
country: France
facility: Centre Hospitalier d'Ajaccio
city: Bron
country: France
facility: Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
city: Dijon
country: France
facility: Service de Réanimation, CHU de Dijon
city: Lyon
country: France
facility: Hôpital Edouard Herriot, Groupement Hospitalier Centre
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Service de Réanimation, Clinique de la Sauvegarde
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Département d'anesthésie réanimation Hôpital Européen Georges Pompidou
city: Vandœuvre-lès-Nancy
country: France
facility: Hôpitaux de Bradois - CHRU Nancy
Study officials:
References: