Fluid OverloadNEPTUNENCT06071026
Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy.
A study testing Net Ultra Filtration Rate in people with Fluid Overload and Hemodynamic Instability, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Net ultra filtration (NUF) is one of the most important parameters during renal replacement therapy (RRT) whose role is to control fluid balance by water removal. To our knowledge, there are no prospective studies or guidelines about the setting of this parameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Hemodynamic Instability
- What is being tested?
- Net Ultra Filtration Rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2023to 8 Jul 2025
- 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
- Patients hospitalised in the intensive care unit of one of the two participating centres
- Patients with Kidney Disease: Improving Global Outcomes 3 (KDIGO3) acute kidney injury (AKI) requiring a continuous RRT during their stay in the intensive care unit, regardless of the aetiology of the AKI
- Need to prescribe water loss by net ultrafiltration (NUF), defined by at least one of the following sub-criteria:
- weight gain ≥ 1 kg relative to entry weight
- oligo-anuria ≥ 24 hours
- clinical impact of fluid overload as judged by the clinician: acute lung oedema clinical or at CT-scan, difficulty of weaning from mechanical ventilation.
Show all 11Show fewer
- Hemodynamic stability in the 2 hours preceding the start of NUF, defined by all of the following sub-criteria:
- absence of vasopressors (noradrenaline) or stability or reduction in their dosage
- no need for resuscitative fluids as judged by the clinician
- Patient or his/her trusted support person/legal representative/family member having given free and informed consent, and having signed the consent form or patient included in an emergency situation.
- Patient affiliated to or benefiting from a health insurance scheme.
Who cannot join
- Patient moribund, with life expectancy too low to benefit from treatment, or with decision to discontinue treatment
- Patient participating in an another interventional study
- Patient in exclusion period determined by another study
- Patient under court protection or guardianship
- Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
- Pregnant, parturient or breast-feeding patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Hemodynamic Effect of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy Sessions for Acute Renal Failure in Intensive Care Patients. Multiple N-of-1 Randomised Bi-centric Controlled Trial.
Net ultra filtration (NUF) is one of the most important parameters during renal replacement therapy (RRT) whose role is to control fluid balance by water removal.
To our knowledge, there are no prospective studies or guidelines about the setting of this parameter.
In the NEPTUNE study, we aim to compare the hemodynamic effect of three NUF rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h.
The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.
Read the detailed description
Renal renal replacement therapy (RRT) for severe acute kidney injury is one of the most widely used life-support techniques in intensive care. One of its main functions is to maintain the water balance in oligo-anuric patients by means of net ultrafiltration (NUF), defined as the volume of water removed from the patient by the RRT per unit time and indexed to the patient's weight.
Surprisingly, the setting of this parameter, which is one of the most important, there are no guidelines. If net ultrafiltration is too low, it may prolong RRT dependency and length of stay in the ICU, with all the associated care-related complications, and increase mortality. If net ultrafiltration is too high, it may transiently induce hypovolemia, leading to hemodynamic instability related to renal replacement therapy (HIRRT).
A recent survey of French practices shows that the average NUF flow rate used in intensive care units in France is 119 ± 77 ml/h, and the median flow rate is 100 ml/h [min-max 20-300]; in this study, NUF was not indexed by weight, but for a patient with an average weight of 75 kg, corresponding to an average NUF of 1.6 ± 1 ml/kg/h.
In the NEPTUNE study, the investigators aim to compare the hemodynamic effect of three net ultrafiltration rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h. These three flow rates are within the range of those usually used in clinical practice.The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.
- Conditions
- Fluid Overload, Hemodynamic Instability
- Being tested
- Net Ultra Filtration Rate
- Keywords
- fluid overload, renal replacement therapy, hemodynamic instability, acute kidney injury
- Medical subject headings
- Edema, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Net Ultra Filtration RateDevice
The net ultra filtration rate is modified every 6 hours accordingly to randomisation
| Study group | Role | What they receive |
|---|---|---|
| 1 ml/kg/h | Experimental | Net ultra filtration setting: 1 ml/kg/h Receives: Device: Net Ultra Filtration Rate |
| 2 ml/kg/h | Experimental | Net ultra filtration setting: 2 ml/kg/h Receives: Device: Net Ultra Filtration Rate |
| 3 ml/kg/h | Experimental | Net ultra filtration setting: 3 ml/kg/h Receives: Device: Net Ultra Filtration Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of HIRRT
Occurrence of Hemodynamic Instability related to Renal Replacement Therapy
Measured: 6 hours
Secondary outcomes (18)
Number of HIRRT
Number of HIRRT episodes in 6-hour sessions, i.e. number of hypotensive episodes during the 6-hour UFN cycle with mean arterial pressure < 65 mmHg [n]
Measured: 6 hours
Water depletion
Total volume of water depleted during 6-hour session [ml/kg/6h]
Measured: 6 hours
Fluid intake
The volume of all fluid intake (resuscitative fluids, transfusions of blood derivatives) during the 6-hour session [ml/kg/6h].
Measured: 6 hours
Time before HIRRT in each session
Time in hours between start of session and onset of hemodynamic instability (h)
Measured: 6 hours
Time between start of RRT and HIRRT
Time in hours between start of RRT and onset of hemodynamic instability (h)
Measured: 28 days
Atrial fibrillation
Proportion of sessions with onset of atrial fibrillation (%)
Measured: 28 days
Variation in norepinephrine
- variation between h0 and h6 in norepinephrine dosage [µg/kg/min].
Measured: 6 hours
Variations in central venous pressure
Variations between h0 and h6 in central venous pressure (CVP) [mmHg].
Measured: 6 hours
Variations in heart rate
Variations between h0 and h6 in heart rate [bpm].
Measured: 6 hours
Variations in arterial pressure
Variations between h0 and h6 in systolic, diastolic and mean arterial pressure (MAP) [mmHg].
Measured: 6 hours
Slope of arterial pressure
Slope of variation in systolic, diastolic and mean arterial pressure between h0 and h6 obtained with repeated hourly measurements
Measured: 6 hours
Frequency of episodes of arterial hypertension
Frequency of episodes between h0 and h6 of arterial hypertension defined by a systolic blood pressure greater than 180 mmHg [n].
Measured: 6 hours
Variations in arterial lactate levels
Variations between h0 and h6 in arterial lactate levels [mmol/l].
Measured: 6 hours
Variations in central venous oxygen saturation (SvcO2)
Variations between h0 and h6 in central venous oxygen saturation (SvcO2) measured in the superior vena cava [%].
Measured: 6 hours
Variations in hematocrit
Variations between h0 and h6 in hematocrit [%].
Measured: 6 hours
Variations in albuminemia
Variations between h0 and h6 in albuminemia [g/L].
Measured: 6 hours
Variations in natremia
Variations in natremia [mmol/L] between h0 and h6
Measured: 6 hours
Frequency of mottling
Frequency of clinical signs/symptoms potentially associated with per-dialytic hypotension during the session: mottling. [n]
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start6 Oct 2023
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Centre Hospitalier Universitaire de NīmesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multiple N of one trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saber D. BARBAR, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071026
- Sponsor's protocol ID
- NIMAO/2022-2/SDB-01
- Acronym
- NEPTUNE
- Status last verified
- Jul 2025
- First submitted
- 19 Sep 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Murugan R, Balakumar V, Kerti SJ, Priyanka P, Chang CH, Clermont G, Bellomo R, Palevsky PM, Kellum JA. Net ultrafiltration intensity and mortality in critically ill patients with fluid overload. Crit Care. 2018 Sep 24;22(1):223. doi: 10.1186/s13054-018-2163-1.
PubMed 30244678Sharma S, Waikar SS. Intradialytic hypotension in acute kidney injury requiring renal replacement therapy. Semin Dial. 2017 Nov;30(6):553-558. doi: 10.1111/sdi.12630. Epub 2017 Jun 30.
PubMed 28666082Murugan R, Kerti SJ, Chang CH, Gallagher M, Neto AS, Clermont G, Ronco C, Palevsky PM, Kellum JA, Bellomo R. Association between Net Ultrafiltration Rate and Renal Recovery among Critically Ill Adults with Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: An Observational Cohort Study. Blood Purif. 2022;51(5):397-409. doi: 10.1159/000517281. Epub 2021 Jul 21.
PubMed 34289471
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Effect of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy Sessions for Acute Renal Failure in Intensive Care Patients. Multiple N-of-1 Randomised Bi-centric Controlled Trial.
- ClinicalTrials.gov ID
- NCT06071026
- Acronym / sponsor ID
- NEPTUNE / NIMAO/2022-2/SDB-01
- Conditions
- Fluid Overload, Hemodynamic Instability
- Keywords
- fluid overload, renal replacement therapy, hemodynamic instability, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 6 Oct 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.
Net ultra filtration (NUF) is one of the most important parameters during renal replacement therapy (RRT) whose role is to control fluid balance by water removal.
To our knowledge, there are no prospective studies or guidelines about the setting of this parameter.
In the NEPTUNE study, we aim to compare the hemodynamic effect of three NUF rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h.
The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.
Detailed description
Renal renal replacement therapy (RRT) for severe acute kidney injury is one of the most widely used life-support techniques in intensive care. One of its main functions is to maintain the water balance in oligo-anuric patients by means of net ultrafiltration (NUF), defined as the volume of water removed from the patient by the RRT per unit time and indexed to the patient's weight.
Surprisingly, the setting of this parameter, which is one of the most important, there are no guidelines. If net ultrafiltration is too low, it may prolong RRT dependency and length of stay in the ICU, with all the associated care-related complications, and increase mortality. If net ultrafiltration is too high, it may transiently induce hypovolemia, leading to hemodynamic instability related to renal replacement therapy (HIRRT).
A recent survey of French practices shows that the average NUF flow rate used in intensive care units in France is 119 ± 77 ml/h, and the median flow rate is 100 ml/h [min-max 20-300]; in this study, NUF was not indexed by weight, but for a patient with an average weight of 75 kg, corresponding to an average NUF of 1.6 ± 1 ml/kg/h.
In the NEPTUNE study, the investigators aim to compare the hemodynamic effect of three net ultrafiltration rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h. These three flow rates are within the range of those usually used in clinical practice.The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Multiple N of one trial
| Arm | Type | Receives |
|---|---|---|
| 1 ml/kg/h | Experimental | Device: Net Ultra Filtration RateNet ultra filtration setting: 1 ml/kg/h |
| 2 ml/kg/h | Experimental | Device: Net Ultra Filtration RateNet ultra filtration setting: 2 ml/kg/h |
| 3 ml/kg/h | Experimental | Device: Net Ultra Filtration RateNet ultra filtration setting: 3 ml/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients hospitalised in the intensive care unit of one of the two participating centres
- Patients with Kidney Disease: Improving Global Outcomes 3 (KDIGO3) acute kidney injury (AKI) requiring a continuous RRT during their stay in the intensive care unit, regardless of the aetiology of the AKI
- Need to prescribe water loss by net ultrafiltration (NUF), defined by at least one of the following sub-criteria:
- Hemodynamic stability in the 2 hours preceding the start of NUF, defined by all of the following sub-criteria:
- Patient or his/her trusted support person/legal representative/family member having given free and informed consent, and having signed the consent form or patient included in an emergency situation.
Key exclusion criteria (6 listed)
- Patient moribund, with life expectancy too low to benefit from treatment, or with decision to discontinue treatment
- Patient participating in an another interventional study
- Patient in exclusion period determined by another study
- Patient under court protection or guardianship
- Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
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 |
|---|---|---|
| Net Ultra Filtration RateThe net ultra filtration rate is modified every 6 hours accordingly to randomisation | Device | 1 ml/kg/h, 2 ml/kg/h, 3 ml/kg/h |
Primary outcome
Occurrence of HIRRT
Time frame: 6 hours
Occurrence of Hemodynamic Instability related to Renal Replacement Therapy
18 secondary outcomes
Number of HIRRT
Time frame: 6 hours
Water depletion
Time frame: 6 hours
Fluid intake
Time frame: 6 hours
Time before HIRRT in each session
Time frame: 6 hours
Time between start of RRT and HIRRT
Time frame: 28 days
Atrial fibrillation
Time frame: 28 days
Variation in norepinephrine
Time frame: 6 hours
Variations in central venous pressure
Time frame: 6 hours
Variations in heart rate
Time frame: 6 hours
Variations in arterial pressure
Time frame: 6 hours
Slope of arterial pressure
Time frame: 6 hours
Frequency of episodes of arterial hypertension
Time frame: 6 hours
Variations in arterial lactate levels
Time frame: 6 hours
Variations in central venous oxygen saturation (SvcO2)
Time frame: 6 hours
Variations in hematocrit
Time frame: 6 hours
Variations in albuminemia
Time frame: 6 hours
Variations in natremia
Time frame: 6 hours
Frequency of mottling
Time frame: 6 hours
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 17 Nov 2025.
- Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 30244678Murugan R, Balakumar V, Kerti SJ, Priyanka P, Chang CH, Clermont G, Bellomo R, Palevsky PM, Kellum JA. Net ultrafiltration intensity and mortality in critically ill patients with fluid overload. Crit Care. 2018 Sep 24;22(1):223. doi: 10.1186/s13054-018-2163-1.
- Background: PubMed 28666082Sharma S, Waikar SS. Intradialytic hypotension in acute kidney injury requiring renal replacement therapy. Semin Dial. 2017 Nov;30(6):553-558. doi: 10.1111/sdi.12630. Epub 2017 Jun 30.
- Background: PubMed 34289471Murugan R, Kerti SJ, Chang CH, Gallagher M, Neto AS, Clermont G, Ronco C, Palevsky PM, Kellum JA, Bellomo R. Association between Net Ultrafiltration Rate and Renal Recovery among Critically Ill Adults with Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: An Observational Cohort Study. Blood Purif. 2022;51(5):397-409. doi: 10.1159/000517281. Epub 2021 Jul 21.
- Individual participant dataSharing planned: Undecided
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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.
Saber D. BARBAR, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Net Ultra Filtration Rate in people with Fluid Overload and Hemodynamic Instability, run by Centre Hospitalier Universitaire de Nīmes 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 11 inclusion and 6 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 17 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?
Occurrence of HIRRT (time frame: 6 hours). 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 NCT06071026, which also lists 4 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 17 Nov 2025.