Acute Kidney InjuryEarlyDryNCT05817539
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
A study testing Fluid balance negativation and Body weight Stabilization in people with Acute Kidney Injury and Fluid Overload, run by Hospices Civils de Lyon at 14 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Fluid Overload
- What is being tested?
- Fluid balance negativation and Body weight Stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 14 sitesFrance
- Study dates
- 15 Dec 2023to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- TRC > 3s at the finger
Show all 12Show fewer
- 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).
Who cannot join
- 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,
- Interventional study participation or exclusion period on going,that may interfere with the present study
Show all 9Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Centre Hospitalier d'Ajaccio
Ajaccio, 20090
Marie Geniez, Md, 04 95 29 91 25 ext. +33, marie.geniez@ch-ajaccio.fr
Marie Geniez, MD
- Recruiting
CHU Amiens-Picardie
Amiens, 80480
Osama ABOU ARAB, Pr, 03 22 08 78 36 ext. +33, abouarab.osama@chu-amiens.fr
Osama ABOU ARAB, Pr
- Recruiting
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, 69500
Matthias JACQUET LAGREZE, MD, 04 72 35 79 41 ext. +33, Matthias.jacquet-lagreze@chu-lyon.fr
- Not yet recruiting
CHU Caen Normandie
Caen, 14033
Sébastien DERVILLE, Dr, 02 31 06 47 36 ext. +33, derville-s@chu-caen.fr
Sébastien DERVILLE, Dr
- Recruiting
Service de Réanimation, CHU de Dijon
Dijon, 21000
Pierre-Grégoire GUINOT, MD, 03 80 29 56 03 ext. +33, pierregregoire.guinot@chu-dijon.fr
- Recruiting
GHP Saint Joseph Marie Lannelongue
Le Plessis-Robinson, 92350
Thibaut GENTY, Dr, 01 40 94 22 60 ext. +33, t.genty@ghpsj.fr
Thibaut GENTY, Dr
- Recruiting
CHU Lille - Hôpital Roger Salengro
Lille, 59037
Laurent ROBRIQUET, Dr, 03 20 44 40 84 ext. +33, Laurent.ROBRIQUET@chu-lille.fr
Laurent ROBRIQUET, Dr
- Recruiting
Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, 69003
Céline MONARD, MD, 0472110164 ext. +33, celine.monard@chu-lyon.fr
Céline MONARD, MD
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Laurent Bitker, MD, 04 26 10 92 69 ext. +33, laurent.bitker@chu-lyon.fr
Laurent Bitker, MD
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Marie-Charlotte Delignette, MD, 04 72 11 89 47 ext. 33, marie-charlotte.delignette@chu-lyon.fr
Marie-Charlotte Delignette, MD
- Recruiting
Service de Réanimation, Clinique de la Sauvegarde
Lyon, 69009
Guillaume Boulay, MD, 04 78 64 06 50 ext. +33, guillaumeboulay85@gmail.com
Guillaume Boulay, MD
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Martin COUR, MD, 04 72 11 28 62 ext. 33, martin.cour@chu-lyon.fr
Martin COUR, MD
- Recruiting
Département d'anesthésie réanimation Hôpital Européen Georges Pompidou
Paris, 75015
Nicolas POLGE, MD, 01 56 09 34 25 ext. +33, nicolas.polge@aphp.fr
- Recruiting
Hôpitaux de Bradois - CHRU Nancy
Vandœuvre-lès-Nancy, 54511
Philippe GUERCI, Professor, 03 83 15 79 95 ext. +33, P.GUERCI@chru-nancy.fr
Philippe GUERCI, Professor
About this study
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
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.
Read more
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
- Conditions
- Acute Kidney Injury, Fluid Overload
- Being tested
- Fluid balance negativation, Body weight Stabilization
- Keywords
- Renal Replacement Therapy (RRT), Ultrafiltration, Deresuscitation, Fluid balance, Fluid overload, Tissue perfusion
- Medical subject headings
- Acute Kidney Injury, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid balance negativationProcedure or surgery
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 StabilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Body weight Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (11)
Mortality decrease
Number of deaths
Measured: 30 days
Number of renal replacement therapy-free days increase
Number of renal replacement therapy-free days
Measured: Day 30
Number of ventilator-free day increase
Number of ventilator-free day
Measured: Day 30
Number of vasopressor-free day increase
Number of vasopressor-free day
Measured: Day 30
Duration of intensive care unit stay
Number of days in ICU
Measured: Up to Day 30
SOFA score evolution
SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse)
Measured: 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
Measured: From Day 0 up to Day 5
Incidence of intestinal ischemia in both group
Number of intestinal ischemia on CT scan or endoscopy
Measured: From Day 0 to Day 30
Incidence of strokes
Number of ischemic strokes occurrence on imagery
Measured: 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
Measured: Between Day 0 and Day 5
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 %
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Dec 2023
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817539
- Sponsor's protocol ID
- 69HCL22_1095
- Acronym
- EarlyDry
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05817539
- Acronym / sponsor ID
- EarlyDry / 69HCL22_1095
- Conditions
- Acute Kidney Injury, Fluid Overload
- Keywords
- Renal Replacement Therapy (RRT), Ultrafiltration, Deresuscitation, Fluid balance, Fluid overload, Tissue perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corrective strategy | Experimental | Procedure: Fluid balance negativationIn 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 | Procedure: Body weight StabilizationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid balance negativationDuring 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. | Procedure or surgery | Corrective strategy |
| Body weight StabilizationDuring 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. | Procedure or surgery | Stabilizing strategy |
Primary outcome
Number of organ replacement free-days
Time frame: Day 30
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.
11 secondary outcomes
Mortality decrease
Time frame: 30 days
Number of renal replacement therapy-free days increase
Time frame: Day 30
Number of ventilator-free day increase
Time frame: Day 30
Number of vasopressor-free day increase
Time frame: Day 30
Duration of intensive care unit stay
Time frame: Up to Day 30
SOFA score evolution
Time frame: From Day 0 up to Day 5
Incidence of arrhythmias and cardiac conduction disorders in both group
Time frame: From Day 0 up to Day 5
Incidence of intestinal ischemia in both group
Time frame: From Day 0 to Day 30
Incidence of strokes
Time frame: From Day 0 to Day 30
Incidence of delirium
Time frame: Between Day 0 and Day 5
Renal recovery assessment
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Recruiting
Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes
Type 2 Diabetes Mellitus, Acute Kidney Injury
RecruitingObservational study
PREdiction of succeSSful weanING From Continuous Renal Replacement Theraphy: the Possible Role of Delta C-cistatin
Acute Kidney Injury
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
Not yet recruiting
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
Acute Kidney Injury (AKI)
RecruitingPhase 2
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
Kidney Injury, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid balance negativation and Body weight Stabilization in people with Acute Kidney Injury and Fluid Overload, run by Hospices Civils de Lyon at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias JACQUET LAGREZE, MD PhD (04 72 35 79 41 ext. +33, Matthias.jacquet-lagreze@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of organ replacement free-days (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.