NCT05817539

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2023Jan 2028

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

April 5, 2023

Last Update Submit

January 7, 2026

Conditions

Acute Kidney InjuryFluid Overload

Keywords

Renal Replacement Therapy (RRT)UltrafiltrationDeresuscitationFluid balanceFluid overloadTissue perfusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Mortality decrease

    30 days

  • Number of renal replacement therapy-free days increase

    Day 30

  • Number of ventilator-free day increase

    Day 30

  • Number of vasopressor-free day increase

    Day 30

  • Duration of intensive care unit stay

    Up to Day 30

  • +6 more secondary outcomes

Study Arms (2)

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.

Procedure: Fluid balance negativation

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.

Procedure: Body weight Stabilization

Interventions

Fluid balance negativationPROCEDURE

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.

Corrective strategy
Body weight StabilizationPROCEDURE

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.

Stabilizing strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),
  • Norepinephrine \< 0,5 µg/kg/min,
  • 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%,
  • 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).

You may not qualify if:

  • Chronic renal failure hemodialyzed before admission to the ICU,
  • Mechanical circulatory support (ECMO, LVAD),
  • Pregnant, child -bearing age or lactating women,
  • Stroke based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less than 30 days,
  • Intestinal ischemia less than 7 days documented non-operated,
  • Guardianship, curatorship or safeguard of justice,
  • Absence of signature of free and informed consent by the patient and/or relative,
  • Patients not affiliated to a social security scheme or beneficiaries of a similar scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Centre Hospitalier d'Ajaccio

Ajaccio, 20090, France

NOT YET RECRUITING

CHU Amiens-Picardie

Amiens, 80480, France

NOT YET RECRUITING

Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

CHU Caen Normandie

Caen, 14033, France

NOT YET RECRUITING

Service de Réanimation, CHU de Dijon

Dijon, 21000, France

RECRUITING

GHP Saint Joseph Marie Lannelongue

Le Plessis-Robinson, 92350, France

NOT YET RECRUITING

CHU Lille - Hôpital Roger Salengro

Lille, 59037, France

NOT YET RECRUITING

Hôpital Edouard Herriot, Groupement Hospitalier Centre

Lyon, 69003, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, 69004, France

NOT YET RECRUITING

Hôpital de la Croix Rousse

Lyon, 69004, France

RECRUITING

Service de Réanimation, Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69437, France

NOT YET RECRUITING

Département d'anesthésie réanimation Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Hôpitaux de Bradois - CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryEdema

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Matthias JACQUET LAGREZE, MD PhD

CONTACT

04 72 35 79 41Matthias.jacquet-lagreze@chu-lyon.fr

Julia CANTERINI, project manager

CONTACT

04 27 85 66 28Julia.canterini@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

December 15, 2023

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(14)