Fluid OverloadGO-NEUTRALNCT04801784
Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)
A study testing Increased net ultrafiltration with advanced hemodynamic monitoring and Zero or near-zero net ultrafiltration in people with Fluid Overload, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload
- What is being tested?
- Increased net ultrafiltration with advanced hemodynamic monitoring and Zero or near-zero net ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2021to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient 18 yo or more, affiliated to a social security system
- Treated with vasopressors for acute circulatory failure
- With KDIGO stage 3 acute kidney injury
- Treated with continuous renal replacement therapy for less than 24 jours
- Monitored with a calibrated continuous cardiac output device
Who cannot join
- Treatment by ECMO (extracorporeal membrane oxygenation)
- Active hemorrhage necessitating transfusion
- Maintenance dialysis or renal graft recipient
- Switch to intermittent hemodialysis is scheduled in the next 72 hours
- Acute cerebral stroke complicated by coma and under mechanical ventilation
- Acute fulminant hepatitis
Show all 13Show fewer
- Postural maneuver (passive leg raising or Trendelenburg) cannot be performed (amputation, inferior vena cava obstruction)
- Pregnancy or lactating
- Withdrawal or limitation of care
- Moribund patient
- Patient under protective measures/wardship
- Inclusion in another trial whose main outcome is cumulative fluid balance, or whose intervention targets hemodynamic physiology, fluid balance or net ultrafiltration.
- Patient previously enrolled in the same study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.
The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.
- Conditions
- Fluid Overload
- Being tested
- Increased net ultrafiltration with advanced hemodynamic monitoring, Zero or near-zero net ultrafiltration
- Keywords
- Fluid Overload, fluid balance, continuous renal replacement therapy, net ultrafiltration, acute kidney injury, hemodynamic monitoring, preload dependence, hemodynamic instability, acute circulatory failure, shock, deresuscitation
- Medical subject headings
- Edema, Acute Kidney Injury, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased net ultrafiltration with advanced hemodynamic monitoringProcedure or surgery
A net ultrafiltration rate of 100 ml/h or more will be applied during the first 72 hours of study participation. To insure the hemodynamic security of the intervention, it is associated with an advanced hemodynamic monitoring protocol which encompasses cardiac index, preload dependence assessment (using postural maneuvers), lactate levels and central venous pressure evaluation. The hemodynamic monitoring protocol allows the decrease or suspension of the neutral ultrafiltration rate in case of hemodynamic instability or of hemodynamic status considered at risk of worsening if net ultrafiltration rate is maintained.
Zero or near-zero net ultrafiltrationProcedure or surgery
The active control group aims to represent the present standard of care of net ultrafiltration management in the first 72 hours of study participation in patients with critical illness. This will be performed by setting the net ultrafiltration rate to 0 up to 25 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Fluid balance neutralization | Experimental | Fluid balance neutralization using increased net ultrafiltration, aiming to neutralize the cumulative fluid input received over the first 72 hours of study participation. Receives: Procedure: Increased net ultrafiltration with advanced hemodynamic monitoring |
| Standard care | Active comparator | Active control group of positive fluid balance during the first 72 hours of study participation with zero or near-zero net ultrafiltration. Receives: Procedure: Zero or near-zero net ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fluid balance
The cumulative fluid balance (in ml) will be calculated as the total amount of input received by the patients (including IV fluids and medications, blood products, hydration and nutrition), minus the total output over the same period of time (including urine output, net ultrafiltration, and drains). The cumulative fluid balance at H72 will be compared between study groups in alive patients at H72.
Measured: 72 hours from study inclusion (H72)
Secondary outcomes (16)
Number of hemodynamic episodes
Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure < 65 mm Hg and requiring urgent intervention, a decrease in cardiac index > 15%, or tachycardia > 120 beats per minute (bpm).
Measured: 72 hours from study inclusion
Number of hemodynamic episodes with preload dependence status
Hemodynamic episodes defined as stated above, that were associated with preload dependence, defined as a significant increase in cardiac index when performing a postural maneuver. This test will be performed every 4 hours as part of the hemodynamic protocol
Measured: 72 hours from study inclusion
Number of Major Adverse Kidney Events (MAKE)
MAKE is a composite criterion applied to participants, composed of either the persistence of renal impairment at Day90 (defined as a serum creatinine > 2 x baseline value), renal replacement therapy dependence at Day90, or death at Day90. A separate analysis of each components of the MAKE 90 outcome will be performed.
Measured: 90 days from study inclusion
Mean arterial pressure
Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Measured: Every 4 hours from inclusion to 72 hours after inclusion
Cardiac index
Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Measured: Every 4 hours from inclusion to 72 hours after inclusion
Lactatemia
Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Measured: Every 4 hours from inclusion to 72 hours after inclusion
Vasopressor dose administered
Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention
Measured: Every 4 hours from inclusion to 72 hours after inclusion
Cumulative fluid balance
The cumulative fluid balance will be calculated as stated for the primary outcome at Hours24. It will be estimated using body weight variation between inclusion and day 7.
Measured: 24 hours and day 7 from study inclusion
Cumulative net ultrafiltration
The cumulative net ultrafiltration is reported by CRRT (continuous renal replacement therapy) generators ad collected every 4 hours from inclusion to 72 hours after inclusion.
Measured: 24 hours, 72 hours and day 7 from study inclusion
Number of respiratory and circulatory failure free days
Organ failure free days are defined as the number of days without organ support, and censored at 28 days of inclusion. Weaning of mechanical ventilation is defined as being free of IMV for 48 hours or more. Weaning of vasopressor is defined as being free of any vasopressor administration for 48 hours or more. Participant who die are over the 28-day period are assigned a value of 0 organ failure free days.
Measured: Day 28 of study inclusion
Severity of organ failures using the SOFA score
Organ failure severity is quantified using the SOFA score (Sepsis-related organ failure assessment), and is collected at inclusion, and daily until Hours 72. The SOFA score assesses 6 physiological systems: respiratory, circulatory, coagulation, liver, renal and neurological.
Measured: from inclusion to 72 hours of study inclusion
PaO2/FiO2 ratio
Intensity of pulmonary hydrostatic edema will be quantified using the PaO2/FiO2 ratio variation from inclusion to Hours24, Hours48 and Hours72 of study inclusion
Measured: 24 hours, 48 hours, and 72 hours from study inclusion
Extravascular lung water index
Intensity of pulmonary hydrostatic edema will be quantified using the extravascular lung water index reported by the continuous cardiac monitoring device, from inclusion to Hours24, Hours48 and Hours72 of study inclusion
Measured: 24 hours, 48 hours, and 72 hours from study inclusion
Hospitalisation duration
Hospitalisation duration will be quantified as the delay between participant admission and discharge from hospital, censored at day 90 from inclusion.
Measured: Day 90 of study inclusion
Duration of stay in Intensive Care Unit (ICU)
Duration of stay in ICU will be quantified as the delay between participant admission and discharge from ICU, censored at day 90 from inclusion
Measured: Day 90 of study inclusion
Survival
Vital status (death/alive) will be reported at D28 and D90 of study inclusion.
Measured: Day 28 and 90 of study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start30 Jun 2021
- Primary completion18 Apr 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies 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
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BITKER, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801784
- Sponsor's protocol ID
- 69HCL20_1243
- Other IDs
- 2021-A00692-39
- Acronym
- GO-NEUTRAL
- Status last verified
- Nov 2025
- First submitted
- 12 Mar 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bitker L, Pradat P, Dupuis C, Klouche K, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in critically ill patients requiring continuous renal replacement therapy: study protocol of the GO NEUTRAL randomized controlled trial. Trials. 2022 Sep 22;23(1):798. doi: 10.1186/s13063-022-06735-6.
PubMed 36138465Bitker L, Dupuis C, Pradat P, Deniel G, Klouche K, Mezidi M, Chauvelot L, Yonis H, Baboi L, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in patients with acute circulatory failure requiring continuous renal replacement therapy: results of the GO NEUTRAL randomized controlled trial. Intensive Care Med. 2024 Dec;50(12):2061-2072. doi: 10.1007/s00134-024-07676-1. Epub 2024 Oct 17.
PubMed 39417870
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study
- ClinicalTrials.gov ID
- NCT04801784
- Acronym / sponsor ID
- GO-NEUTRAL / 69HCL20_1243
- Conditions
- Fluid Overload
- Keywords
- Fluid Overload, fluid balance, continuous renal replacement therapy, net ultrafiltration, acute kidney injury, hemodynamic monitoring, preload dependence, hemodynamic instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 17 Mar 2021 (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.
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.
The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid balance neutralization | Experimental | Procedure: Increased net ultrafiltration with advanced hemodynamic monitoringFluid balance neutralization using increased net ultrafiltration, aiming to neutralize the cumulative fluid input received over the first 72 hours of study participation. |
| Standard care | Active comparator | Procedure: Zero or near-zero net ultrafiltrationActive control group of positive fluid balance during the first 72 hours of study participation with zero or near-zero net ultrafiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient 18 yo or more, affiliated to a social security system
- Treated with vasopressors for acute circulatory failure
- With KDIGO stage 3 acute kidney injury
- Treated with continuous renal replacement therapy for less than 24 jours
- Monitored with a calibrated continuous cardiac output device
Key exclusion criteria (13 listed)
- Treatment by ECMO (extracorporeal membrane oxygenation)
- Active hemorrhage necessitating transfusion
- Maintenance dialysis or renal graft recipient
- Switch to intermittent hemodialysis is scheduled in the next 72 hours
- Acute cerebral stroke complicated by coma and under mechanical ventilation
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 |
|---|---|---|
| Increased net ultrafiltration with advanced hemodynamic monitoringA net ultrafiltration rate of 100 ml/h or more will be applied during the first 72 hours of study participation. To insure the hemodynamic security of the intervention, it is associated with an advanced hemodynamic monitoring protocol which encompasses cardiac index, preload dependence assessment (using postural maneuvers), lactate levels and central venous pressure evaluation. The hemodynamic monitoring protocol allows the decrease or suspension of the neutral ultrafiltration rate in case of hemodynamic instability or of hemodynamic status considered at risk of worsening if net ultrafiltration rate is maintained. | Procedure or surgery | Fluid balance neutralization |
| Zero or near-zero net ultrafiltrationThe active control group aims to represent the present standard of care of net ultrafiltration management in the first 72 hours of study participation in patients with critical illness. This will be performed by setting the net ultrafiltration rate to 0 up to 25 ml/h. | Procedure or surgery | Standard care |
Primary outcome
Cumulative fluid balance
Time frame: 72 hours from study inclusion (H72)
The cumulative fluid balance (in ml) will be calculated as the total amount of input received by the patients (including IV fluids and medications, blood products, hydration and nutrition), minus the total output over the same period of time (including urine output, net ultrafiltration, and drains). The cumulative fluid balance at H72 will be compared between study groups in alive patients at H72.
16 secondary outcomes
Number of hemodynamic episodes
Time frame: 72 hours from study inclusion
Number of hemodynamic episodes with preload dependence status
Time frame: 72 hours from study inclusion
Number of Major Adverse Kidney Events (MAKE)
Time frame: 90 days from study inclusion
Mean arterial pressure
Time frame: Every 4 hours from inclusion to 72 hours after inclusion
Cardiac index
Time frame: Every 4 hours from inclusion to 72 hours after inclusion
Lactatemia
Time frame: Every 4 hours from inclusion to 72 hours after inclusion
Vasopressor dose administered
Time frame: Every 4 hours from inclusion to 72 hours after inclusion
Cumulative fluid balance
Time frame: 24 hours and day 7 from study inclusion
Cumulative net ultrafiltration
Time frame: 24 hours, 72 hours and day 7 from study inclusion
Number of respiratory and circulatory failure free days
Time frame: Day 28 of study inclusion
Severity of organ failures using the SOFA score
Time frame: from inclusion to 72 hours of study inclusion
PaO2/FiO2 ratio
Time frame: 24 hours, 48 hours, and 72 hours from study inclusion
Extravascular lung water index
Time frame: 24 hours, 48 hours, and 72 hours from study inclusion
Hospitalisation duration
Time frame: Day 90 of study inclusion
Duration of stay in Intensive Care Unit (ICU)
Time frame: Day 90 of study inclusion
Survival
Time frame: Day 28 and 90 of study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 36138465Bitker L, Pradat P, Dupuis C, Klouche K, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in critically ill patients requiring continuous renal replacement therapy: study protocol of the GO NEUTRAL randomized controlled trial. Trials. 2022 Sep 22;23(1):798. doi: 10.1186/s13063-022-06735-6.
- Derived from this study: PubMed 39417870Bitker L, Dupuis C, Pradat P, Deniel G, Klouche K, Mezidi M, Chauvelot L, Yonis H, Baboi L, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in patients with acute circulatory failure requiring continuous renal replacement therapy: results of the GO NEUTRAL randomized controlled trial. Intensive Care Med. 2024 Dec;50(12):2061-2072. doi: 10.1007/s00134-024-07676-1. Epub 2024 Oct 17.
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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. This study is not recruiting at the moment.
Laurent BITKER principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased net ultrafiltration with advanced hemodynamic monitoring and Zero or near-zero net ultrafiltration in people with Fluid Overload, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance (time frame: 72 hours from study inclusion (H72)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801784, which also lists 2 linked publications.
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 21 Nov 2025.