Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure

Acute Kidney Injury Clinical Trial

— EarlyDry  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817539
• Other study ID #: 69HCL22_1095
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Matthias JACQUET LAGREZE, MD PhD
• Phone: 04 72 35 79 41
• Email: Matthias.jacquet-lagreze[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (oxygen therapy or vascular filling > 1000ml),

3. Cumulative UF net less than 1000ml 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fluid Overload
• Renal Insufficiency

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier d'Ajaccio	Ajaccio
France	Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon	Bron
France	Service de Réanimation, CHU de Dijon	Dijon
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Edouard Herriot, Groupement Hospitalier Centre	Lyon
France	Service de Réanimation, Clinique de la Sauvegarde	Lyon
France	Département d'anesthésie réanimation Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Mortality decrease	Number of deaths	30 days
Secondary	Number of renal replacement therapy-free days increase	Number of renal replacement therapy-free days	Day 30
Secondary	Number of ventilator-free day increase	Number of ventilator-free day	Day 30
Secondary	Number of vasopressor-free day increase	Number of vasopressor-free day	Day 30
Secondary	Duration of intensive care unit stay	Number of days in ICU	Up to Day 30
Secondary	SOFA score evolution	SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse)	From Day 0 up to Day 5
Secondary	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
Secondary	Incidence of intestinal ischemia in both group	Number of intestinal ischemia on CT scan or endoscopy	From Day 0 to Day 30
Secondary	Incidence of strokes	Number of ischemic strokes occurrence on imagery	From Day 0 to Day 30
Secondary	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
Secondary	Renal recovery assessment	Renal recovery is defined according to MAKE 30 scale : Survival; Absence of renal replacement therapy; Day 30 creatinine level < baseline creatinine x 200 %	Day 30